Headgear assembly and interface assembly having headgear

Abstract

This application relates to headgear assemblies and interface assemblies having headgear. A headgear system and / or an interface assembly comprising a headgear system is disclosed herein, which, in some configurations, is configured to change from an elastic or “loose” behavior to an “inelastic” behavior, at least in response to normal or anticipated forces encountered during the intended treatment. In some configurations, the system automatically adjusts or adapts to an appropriate size when fitted to a user’s head. A headgear portion or assembly for use in conjunction with a respiratory device in some configurations is disclosed herein, which is at least substantially inelastic and three-dimensional in shape. The headgear portion or assembly may include a plastic core and a textile shell. The headgear or a portion thereof may also have integrally molded tags, connectors, adjustment mechanisms, and / or clamps.

Description

[0001] This application is a divisional application of patent application 202110608937.7, filed on June 1, 2021, entitled "Headpiece Assembly and Interface Assembly with Headpiece"; and 202110608937.7 is a divisional application of patent application 201580049820.2, filed on September 16, 2015, entitled "Headpiece Assembly and Interface Assembly with Headpiece".

[0002] Incorporating any priority claim by reference

[0003] All applications claiming foreign or domestic priority in connection with this application are incorporated herein by reference and form part of this disclosure. background Technical Field

[0004] This disclosure relates to a headgear and interface components for use in respiratory therapy. More specifically, this disclosure relates to a substantially inelastic three-dimensional headgear, portions thereof, and a method for molding such a headgear. Further applications of the molding method are also disclosed. Background Technology

[0005] Treatment of respiratory illnesses or conditions through therapies such as NIV, bilevel, or CPAP involves delivering compressed air to a person's airway via a tube and breathing device (e.g., a mask or endotracheal tube). Typically, a mask forms at least a substantial "seal" over or around the user's nose and / or mouth, while an endotracheal tube does not provide a seal but provides a delivery pathway for supplemental respiratory gas delivery.

[0006] The result of this "seal" is that the combination of the closed area of ​​the breathing device and the pressure within it creates a resultant force attempting to push the device away from the face. To counteract this force, a hood consisting of a series of straps is typically used, which wrap around the back and / or top of the user's head. Such hoods are typically made of compliant materials, such as Breath-o-prene. TM The material used results in a relatively small structure for the hood when not being worn. This lack of structure can cause the hood's components to become tangled, potentially making it difficult for the user to put on the hood and breathing equipment.

[0007] The straps require some form of adjustment to accommodate head size, and this adjustment mechanism is typically provided via an adjustment ring between the mask body and the hood. This adjustment ring may have a hook or similar fastener that allows the end of the strap to pass through a mounting position on the mask or through a clip attached to the mask and then to another section of the strap. This adjustment allows the hood to be adjusted by changing the size of the adjustment ring by positioning the end of the strap at a desired location on another section of the strap.

[0008] These types of mechanisms are solutions for providing adjustment mechanisms for headgear and therefore interface components. Such systems also require a reasonable level of user interaction and are therefore prone to misuse or misadjustment (e.g., over-tightening). In practice, making even minor adjustments to such systems is difficult and time-consuming. Developing practical and less practical solutions to this has become the subject of considerable research and development work from several organizations, resulting in numerous patents.

[0009] Furthermore, these traditional headgear are often configured with some elasticity. This can cause the headgear to stretch over the user's head and exert a squeezing force, which can be uncomfortable. It is desirable to develop headgear and breathing devices that are easy to use and comfortable to wear, as this can improve user compliance with the provided therapy. Summary of the Invention

[0010] The systems, methods, and apparatuses described herein have innovative aspects, none of which are indispensable or can alone provide their desired properties. Some advantageous features will now be outlined without limiting the scope of the claims.

[0011] The headgear system and / or the interface components containing the headgear system automatically adjust to the correct size when fitted to the user's head, and once in use, change in nature from elastic "straightening" straps / bandages to "non-elastic" straps / bandages.

[0012] In some configurations, a hood assembly for supporting a breathing interface on a user includes a back hood portion configured to contact the rear and / or upper portion of the user's head. The back hood portion includes a plastic core and a textile shell. The plastic core and the textile shell are formed as a single structure by applying molten plastic material into the textile shell. Each side of the back hood portion includes a mounting portion configured to be positioned in front of the user's ear during use. Interface connection devices are provided on the mounting portions on each side of the hood assembly. Each interface connection device is configured for direct or indirect connection to the breathing interface. Each interface connection device includes at least one length adjustment device. Each length adjustment device includes an elastic element, a core member, and a restraint device. The core member is associated with the elastic element and is fixed relative to one end of the elastic element. The core member passes through the restraint device. The restraint device is configured to selectively engage the core member to resist movement of the core member relative to the restraint device.

[0013] In some configurations, the back cap portion does not have a structure that would prevent the back cap portion from being removed in an upward direction past the user's ears.

[0014] In some configurations, each of these interface connection devices includes at least a first length adjustment device and a second length adjustment device.

[0015] In some configurations, at least one of the first length adjustment device and the second length adjustment device is adjustable in position on the mounting portion.

[0016] In some configurations, each of these mounting portions includes multiple mounting positions for the first length adjustment device and the second length adjustment device, wherein these mounting positions are integrally formed with the plastic core.

[0017] In some configurations, at least one connector is configured to connect these interface connection devices to the breathing interface.

[0018] In some configurations, the at least one connector includes at least one collection channel configured to receive a portion of the core component.

[0019] In some configurations, these restraint devices are located on the back cap section.

[0020] In some configurations, the back cap portion defines at least one collection channel, which is configured to receive a portion of the core component.

[0021] In some configurations, the at least one collection channel is defined by or between the plastic core and the textile housing.

[0022] In some configurations, these restraint devices are located at a distance from the end of the elastic element.

[0023] In some configurations, a guide for a portion of the core component is positioned between the end of the elastic element and the restraint device.

[0024] In some configurations, the elastic element includes a non-elastic portion that constrains the elastic element to its maximum length.

[0025] In some configurations, a hood assembly for supporting a breathing interface on a user includes a back hood portion configured to contact the rear and / or upper portion of the user's head. The back hood portion includes a plastic core and a textile shell. The plastic core and the textile shell are formed as a single structure by applying molten plastic material into the textile shell. Interface connection devices are provided on each side of the hood assembly. Each interface connection device is configured for direct or indirect connection to the breathing interface. Each interface connection device includes at least one length adjustment device. Each length adjustment device includes an elastic element, a core member, and a restraint device. The core member is associated with and fixed relative to one end of the elastic element. The core member passes through the restraint device. The restraint device is configured to selectively engage the core member to resist movement of the core member relative to the restraint device. The at least one restraint device is located on the back hood portion.

[0026] In some configurations, the back cap portion does not have a structure that would prevent the back cap portion from being removed in an upward direction past the user's ears.

[0027] In some configurations, the back cap portion defines at least one collection channel, which is configured to receive a portion of the core component.

[0028] In some configurations, the at least one collection channel is defined by or between the plastic core and the textile housing.

[0029] In some configurations, the restraint device is located at a distance from the other end of the elastic element.

[0030] In some configurations, a guide for a portion of the core component is positioned between the end of the elastic element and the restraint device.

[0031] In some configurations, the elastic element includes a non-elastic portion that constrains the elastic element to its maximum length.

[0032] The headgear system and / or the interface components containing the headgear system automatically adjust to the correct size when fitted to the user's head, and once in use, change in nature from elastic "straightening" straps / bandages to "non-elastic" straps / bandages.

[0033] In some configurations, a hood assembly for supporting a breathing interface on a user includes a substantially inelastic rear portion, a substantially inelastic front portion, a first elastic side portion on a first side of the hood assembly, and a second elastic side portion on a second side of the hood assembly. At least one filament extends through or along the first and second elastic side portions. The at least one filament is coupled to the inelastic rear portion, the inelastic front portion, and one of at least one restraint device. The at least one filament passes through the at least one restraint device. The at least one restraint device is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one restraint device.

[0034] In some configurations, the at least one restraining device is configured to provide a first resistance to the movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from each other.

[0035] In some configurations, the at least one restraining device is configured to provide a second resistance to the movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move toward each other, wherein the second resistance is less than the first resistance.

[0036] In some configurations, the inelastic front portion is rigid.

[0037] In some configurations, the inelastic front portion is configured to be connected to the breathing interface.

[0038] In some configurations, the inelastic front portion defines at least one collection channel that accommodates a portion of the at least one filament.

[0039] In some configurations, each of the first resilient side portion and the second resilient side portion includes an end cap with an opening through which at least one filament passes. The end cap may be overmolded onto a corresponding one of the first resilient side portion and the second resilient side portion. The end cap may be attached to the inelastic front portion.

[0040] In some configurations, the inelastic rear portion, the inelastic front portion, the first elastic side portion, and the second elastic side portion define a closed-loop perimeter.

[0041] In some configurations, the at least one filament includes a first filament associated with the first elastic side portion and a second filament associated with the second elastic side portion. The at least one restraining device may include a first restraining device associated with the first elastic side portion and a second restraining device associated with the second elastic side portion.

[0042] In some configurations, the at least one collection channel includes a first collection channel that houses a portion of the first filament and a second collection channel that houses a portion of the second filament.

[0043] In some configurations, the restraint device includes a pair of locking claws defining a space through which the filament passes. These locking claws have a first relative position engaging the filament to provide a first resistance and a second relative position providing a second resistance.

[0044] In some configurations, the interface includes a forehead support, and the at least one collection channel is located on the forehead support.

[0045] In some configurations, the cap includes upper and lower elastic side portions, upper and lower filaments, and upper and lower restraint devices on each side. In some such configurations, upper and lower collection channels are present. These upper and lower collection channels on each side of the cap can be separated from each other.

[0046] In some configurations, the inelastic front portion defines an opening configured to receive a portion of the breathing interface, wherein the at least one collection channel includes a first collection channel and a second collection channel, wherein at least a portion of the first collection channel is located above the opening and at least a portion of the second collection channel is located below the opening.

[0047] In some configurations, this inelastic front portion is configured to connect to a variety of different interfaces.

[0048] In some configurations, the inelastic front portion includes separate sections located on each side of the cap assembly.

[0049] In some configurations, a headgear assembly for supporting a breathing interface on a user defines a periphery surrounding the user's head. The headgear assembly may include a first portion having a fixed length along the periphery and a second portion having a fixed length along the periphery. At least one elastic portion has a variable length along the periphery, wherein the at least one elastic portion has a first length and a second length greater than the first length. At least one filament is secured to one of the first and second portions and extends through the at least one elastic portion and into at least one collection channel of the other of the first and second portions. The at least one filament has a filament length greater than the second length of the at least one elastic portion. At least one restraint device is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one restraint device. The at least one restraint device is located at an entrance to the at least one collection channel.

[0050] In some configurations, the first part is the front part of the cap assembly.

[0051] In some configurations, the second part is the rear part of the cap assembly.

[0052] In some configurations, the first part defines at least one collection channel.

[0053] In some configurations, the at least one elastic portion is constrained to a maximum length.

[0054] In some configurations, the at least one elastic portion includes an inelastic element that defines the maximum length.

[0055] In some configurations, the at least one elastic portion includes a first elastic portion and a second elastic portion, wherein each of the first elastic portion and the second elastic portion extends between the first portion and the second portion.

[0056] In some configurations, the at least one filament includes a first filament associated with the first elastic portion and a second filament associated with the second elastic portion. The at least one restraining device includes a first restraining device associated with the first elastic side portion and a second restraining device associated with the second elastic side portion.

[0057] In some configurations, the at least one collection channel includes a first collection channel that houses a portion of the first filament and a second collection channel that houses a portion of the second filament.

[0058] In some configurations, the restraint device includes a pair of locking claws defining a space through which the filament passes. These locking claws have a first relative position engaging the filament to provide a first level of resistance and a second relative position providing a second level of resistance below the first level.

[0059] In some configurations, the directional lock includes a housing defining an internal space, a first opening, and a second opening. Each of the first and second openings communicates with the internal space. At least one locking element is pivotally coupled to the housing for rotation about a fixed pivot axis. The locking element has an aperture configured to receive a core element. The locking element is movable between a first position in which the aperture is aligned with the first and second openings, and a second position in which the aperture is not aligned with the first and second openings.

[0060] In some configurations, the locking element is a locking washer.

[0061] In some configurations, at least one of the first opening and the second opening is elongated in a direction perpendicular to the pivot axis, such that the at least one of the first opening and the second opening can accommodate a core element passing through the orifice of the at least one locking element in both the first position and the second position.

[0062] In some configurations, the at least one locking element includes a first locking element and a second locking element.

[0063] In some configurations, the housing includes an inner wall positioned between the first locking element and the second locking element.

[0064] In some configurations, the hood assembly for supporting the breathing interface on a user includes a rear hood portion configured to contact the rear and / or upper portion of the user's head. Each side of the rear hood portion includes a mounting portion configured to be positioned in front of the user's ear during use. The rear hood portion does not have a structure that would prevent removal of the rear hood portion in an upward direction past the user's ear. Interface connection devices are provided on the mounting portions on each side of the hood assembly. Each interface connection device is configured for direct or indirect coupling to the breathing interface. Each interface connection device includes at least one length adjustment device. Each length adjustment device includes an elastic element, a core member, and a restraint device. The core member is associated with the elastic element and is fixed relative to one end of the elastic element. The core member passes through the restraint device. The restraint device is configured to selectively engage the core member to resist movement of the core member relative to the restraint device.

[0065] In some configurations, each of these interface connection devices includes at least a first length adjustment device and a second length adjustment device.

[0066] In some configurations, the first length adjustment device and the second length adjustment device are spaced apart from each other on the mounting portion.

[0067] In some configurations, at least one of the first length adjustment device and the second length adjustment device is adjustable in position on the mounting portion.

[0068] In some configurations, at least one connector is configured to connect these interface connection devices to the breathing interface.

[0069] In some configurations, the at least one connector includes at least one collection channel configured to receive a portion of the core component.

[0070] In some configurations, a single connector is configured to connect all these interface connection devices to the breathing interface.

[0071] In some configurations, the connector defines an opening configured to receive a portion of the breathing interface, wherein the at least one collection channel includes a first collection channel and a second collection channel, wherein at least a portion of the first collection channel is located above the opening and at least a portion of the second collection channel is located below the opening.

[0072] In some configurations, the connector is configured to connect to a variety of different interfaces.

[0073] In some configurations, the at least one connector includes connectors located on each side of the headgear assembly.

[0074] In some configurations, the restraint device includes a pair of locking claws defining a space through which the core member passes. These locking claws have a first relative position engaging the core member to provide a first level of resistance and a second relative position providing a second level of resistance below the first level.

[0075] In some configurations, a hood assembly for supporting a breathing interface on a user includes at least one non-elastic portion and at least one elastic portion having a first end and a second end. At least one filament extends through or along the at least one elastic portion. The first end of the at least one elastic portion is fixed relative to the at least one non-elastic portion and the at least one filament. The second end of the at least one elastic portion is movable relative to the at least one non-elastic portion and the at least one filament. The hood assembly also includes at least one restraint device. The at least one filament passes through the at least one restraint device. The at least one restraint device is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one restraint device. The at least one restraint device is positioned away from each of the first end and the second end of the at least one elastic portion.

[0076] In some configurations, the non-elastic portion is a hood portion configured to contact the rear and / or upper portion of the user's head during use, wherein the at least one restraint device is located on the hood portion.

[0077] In some configurations, the hood portion includes a top strap and the at least one restraint device is located on the top strap.

[0078] In some configurations, the headgear assembly is configured such that the at least one restraint device is located on top of the user's head during use.

[0079] In some configurations, the hood portion includes a back strap and the at least one restraint device is located on the back strap.

[0080] In some configurations, the headgear assembly is configured such that the at least one restraint device is located behind the user's ear during use.

[0081] In some configurations, a guide for the at least one filament is disposed between the restraint device and one of the first end and the second end of the at least one elastic portion.

[0082] In some configurations, the restraint device includes a pair of locking claws defining a space through which the filament passes. These locking claws have a first relative position engaging the filament to provide a first level of resistance and a second relative position providing a second level of resistance below the first level.

[0083] In some configurations, the patient interface system includes a body portion sized and shaped to surround the user's nose and / or mouth and adapted to form at least a substantial seal with the user's face. A connector allows the patient interface to be attached to a gas delivery system. Because the cap system provides the ability to switch from elastic elongation behavior to non-elongation behavior, the cap system allows the body portion to be positioned and held on the user's head during use of the interface system.

[0084] In some configurations, this transformation locking behavior is provided by a set of directional locking features.

[0085] In some configurations, this transformation locking behavior is provided by a set of directional locking features located on the fixation plane.

[0086] In some configurations, this transformation locking behavior is provided by a set of directional locking features that enable independent relative movement with respect to each other.

[0087] In some configurations, this transformation locking behavior is provided by a set of directional locking features that have non-independent movement relative to each other.

[0088] In some configurations, the interface system includes a combination of independent and non-independent movement.

[0089] In some configurations, this transformation locking behavior is provided by directional locking features located on the mask body.

[0090] In some configurations, this shift-locking behavior is provided by directional locking features located above or within the cap system.

[0091] In some configurations, a combination of directional locking features located on the mask body and directional locking features located on or within the headgear system is used.

[0092] In some configurations, the directional lock is positioned near the connection point with the cap.

[0093] In some configurations, the directional lock is positioned away from the connection point with the cap.

[0094] In some configurations, the directional lock module includes a mechanism for user attachment / removal from the mask body.

[0095] In some configurations, the directional lock module includes a mechanism for user attachment / removal from the rest of the headgear system.

[0096] In some configurations, the non-stretchable behavior of the headgear system is such that when the patient interface system is subjected to a variable pressure waveform, there is a mask movement of less than 4 mm.

[0097] In some configurations, the patient interface system includes a body portion whose size and shape are configured to provide a gas delivery system into these nasal passages. A connector allows the patient interface to be attached to the gas delivery system. Because the cap system provides the ability to switch from elastic elongation behavior to non-elongation behavior, the cap system allows the body portion to be positioned and held on the user's head during use of the interface system.

[0098] In some configurations, the patient interface system includes a body portion sized and shaped to surround the user's nose and / or mouth and adapted to form at least a substantial seal with the user's face. A connector allows the patient interface to be attached to a gas delivery system. Because the cap system provides the ability to switch from elastic elongation behavior to non-elongation behavior, the cap system allows the body portion to be positioned and held on the user's head during use of the interface system.

[0099] In some configurations, the positional stability of this cap system is achieved via two main parts: one passing over or below the occipital protuberance, and the other loosely passing over the top of the head. The relative positions of these two main parts are maintained by the shape-retaining material of the cap.

[0100] In some configurations, the positional stability of the headgear system is achieved via two main parts: one passing over or below the occipital protuberance, and the other loosely passing over the top of the head. The relative positions of these two main parts are maintained by gusset plates or connecting members.

[0101] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion from a single inelastic material and by using a variable cross-sectional geometry.

[0102] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion from a single thermoplastic material and by using a variable cross-sectional geometry.

[0103] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion from a single thermosetting material and by using a variable cross-sectional geometry.

[0104] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion from a variety of thermoplastic materials.

[0105] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion from a variety of thermosetting materials.

[0106] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion from a variety of thermoplastic materials and by using a variable cross-sectional geometry.

[0107] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion and the included lining or padding material from a thermoplastic material.

[0108] In some configurations, the non-stretch behavior of the body portion of the cap is achieved by constructing the body portion and the included lining or padding material from a thermosetting material.

[0109] In some configurations, the cap assembly for the breathing interface includes a rear cap portion, an interface connection portion, and a length adjustment portion, which adjusts the length of the cap assembly or the perimeter length of the interface assembly when connected to the breathing interface. The cap assembly exhibits an elastic force that tends to contract the cap length or the perimeter length and an inelastic locking force that tends to inhibit the elongation of the cap length or the perimeter length.

[0110] In some configurations, the cap assembly includes at least one retaining plane.

[0111] In some configurations, the cap assembly includes two retaining planes.

[0112] In some configurations, these retaining planes converge in the direction of movement from the rear to the front.

[0113] In some configurations, these locating planes converge in the direction of movement from the front to the rear.

[0114] In some configurations, one of these retaining planes is at an angle relative to the other retaining plane.

[0115] In some configurations, these retaining planes are separated from each other at these interface attachment locations.

[0116] In some configurations, these locating planes are generally parallel to each other.

[0117] In some configurations, these locating planes are generally horizontal.

[0118] In some configurations, the cap assembly also includes a manually adjustable length adjustment section.

[0119] In some configurations, this interface connection part can be connected to multiple types of interfaces.

[0120] In some configurations, the length adjustment portion includes at least a first portion and a second portion.

[0121] In some configurations, the first part and the second part are located on opposite sides of the cap assembly.

[0122] In some configurations, the interface connection portion extends between the first portion and the second portion.

[0123] In some configurations, the first part and the second part are located on the same side of the cap assembly.

[0124] In some configurations, the interface connection portion extends between the first portion and the second portion.

[0125] In some configurations, at least one core member forms a portion of the cap length or the perimeter length and can be locked relative to another portion of the cap assembly or interface assembly to prevent elongation of the cap length or the perimeter length.

[0126] In some configurations, the length of the core component is greater than the maximum extension length of the length adjustment portion.

[0127] In some configurations, the length of the back cap portion is greater than or equal to the length of the core component.

[0128] In some configurations, at least one core collector accommodates an excess portion of the core, which does not form part of any given cap length or perimeter length.

[0129] In some configurations, the length of the core component is less than the length of the combined core collector and the maximum extension length of the length adjustment portion.

[0130] In some configurations, the length of the back cap portion and the length of the core collector are fixed, and adjusting the length of the length adjustment member provides substantially all length adjustments to the cap length or the perimeter length.

[0131] In some configurations, the nasal cannula system includes a nasal cannula and a cap. At least one adjustment device allows adjustment of the circumferential length of the nasal cannula system. The at least one adjustment device includes a core member coupled to one of the cap and the nasal cannula, and a lock coupled to the other of the cap and the nasal cannula. The lock can engage the core member to hold the nasal cannula system at the desired adjusted circumferential length.

[0132] In some configurations, the lock can maintain the desired adjusted perimeter length in response to normal or anticipated forces during use (such as the weight of the nasal cannula and the tension of the tubing).

[0133] In some configurations, the lock allows the core component to slide under forces exceeding a threshold, thus enabling the perimeter length to increase beyond the desired adjusted perimeter length.

[0134] In some configurations, the lock is a directional lock and allows the core component to move in a direction that reduces the perimeter length under relatively low force, less than the normal or expected force in use.

[0135] In some configurations, the directional lock has any of the structures or arrangements disclosed herein.

[0136] In some configurations, at least one biasing element applies a force to the nasal cannula system that tends to reduce the perimeter length.

[0137] In some configurations, the biasing element allows the nasal cannulation system to be self-adjusting or automatically adjustable.

[0138] In some configurations, the nasal cannula system includes at least one quick-release device that allows the peripheral ring to be quickly and easily disconnected for purposes such as removing the nasal cannula system from or applying it to the user.

[0139] In some configurations, the cap is a single strap or a forked strap device.

[0140] In some configurations, the nasal cannula includes a body having a rigid frame portion and a softer portion that contacts the user.

[0141] In some configurations, an excess portion of the at least one core member that does not effectively define a portion of the circumferential length is accommodated within the nasal cannula or the head cap. In some such configurations, the excess portion is inside the nasal cannula or the head cap. In some such configurations, the excess portion is accommodated within a circular accumulator.

[0142] In some configurations, multiple adjustment devices are provided. In some such configurations, adjustment devices are provided on each side of the nasal cannula system. In some such configurations, the excess portions of these core components on each side are positioned vertically above or within the nasal cannula.

[0143] In some configurations, the nasal cannula system includes a nasal cannula and a head cap. At least one adjustment device allows adjustment of the circumferential length of the nasal cannula system. The at least one adjustment device includes a core member coupled to one portion of the head cap and a lock coupled to another portion of the head cap, the other portion being movable relative to the first portion. The lock can engage the core member to hold the nasal cannula system at the desired adjusted circumferential length.

[0144] In some configurations, the lock can maintain the desired adjusted perimeter length in response to normal or anticipated forces during use (such as the weight of the nasal cannula and the tension of the tubing).

[0145] In some configurations, the lock allows the core component to slide under forces exceeding a threshold, thus enabling the perimeter length to increase beyond the desired adjusted perimeter length.

[0146] In some configurations, the lock is a directional lock and allows the core component to move in a direction that reduces the perimeter length under relatively low force, less than the normal or expected force in use.

[0147] In some configurations, the directional lock has any of the structures or arrangements disclosed herein.

[0148] In some configurations, at least one biasing element applies a force to the nasal cannula system that tends to reduce the perimeter length.

[0149] In some configurations, the biasing element allows the nasal cannulation system to be self-adjusting or automatically adjustable.

[0150] In some configurations, the nasal cannula system includes at least one quick-release device that allows the peripheral ring to be quickly and easily disconnected for purposes such as removing the nasal cannula system from or applying it to the user.

[0151] In some configurations, the cap is a single strap or a forked strap device.

[0152] In some configurations, the nasal cannula includes a body having a rigid frame portion and a softer portion that contacts the user.

[0153] In some configurations, an excess portion of the at least one core member that does not effectively define a portion of the circumferential length is accommodated within the cap. In some such configurations, the excess portion is inside the cap. In some such configurations, the excess portion is accommodated within a circular accumulator.

[0154] In some configurations, multiple adjustment devices are provided. In some such configurations, adjustment devices are provided on each side of the nasal cannula system.

[0155] In some configurations, the directional lock includes a locking member having an aperture or opening and configured to engage a core member or filament passing through the opening. The opening may vary the cross-sectional dimensions between one side and the other side of the locking member, and / or the profile of the opening may be tapered.

[0156] In some configurations, the opening defines the side of the locking member that engages the working edge of the core member in the locked position smaller than the opposite side of the opening.

[0157] In some configurations, the outline of the opening tapers toward the pivot axis of the locking member.

[0158] In some configurations, the directional lock includes a first locking member and a second locking member, each having an orifice or opening and configured to engage a core member or filament passing through the opening. A motion transmission element causes the second locking member to move in response to movement of the first locking member.

[0159] In some configurations, the motion transmission element pushes the second locking member in response to the movement of the first locking member, but allows the second locking member to move away from the first locking member.

[0160] In some configurations, the motion transmission element is a linkage that flexes to allow the second locking member to move away from the first locking member.

[0161] According to at least one of the embodiments disclosed herein, a headgear is provided comprising a top strap, a rear strap, a front strap, a yoke, and a connector. The headgear is configured to be substantially inelastic and structurally three-dimensional.

[0162] According to another perspective, the cap is constructed from a composite material, in which a textile shell is integrally molded around a plastic core.

[0163] According to another aspect, the cap includes integrally molded labels, connectors, and / or adjustment features.

[0164] According to another aspect, the headgear component includes clamps molded onto textile straps.

[0165] According to another aspect, the textile housing includes a first portion that covers the inward-facing surface of the headgear.

[0166] According to another aspect, the textile housing includes a second portion that covers the outward-facing surface of the headgear.

[0167] According to another aspect, the first part and the second part of the textile shell meet at the first edge and the second edge.

[0168] According to another aspect, the first part and the second part are not connected to each other at the first edge and the second edge.

[0169] According to another aspect, the textile housing includes one or more locating holes configured for engaging locating pins of a molding tool.

[0170] According to another aspect, the cap includes at least one flexible joint that allows the straps to bend.

[0171] According to another aspect, the at least one flexible joint includes a gap between portions of a plastic core, and wherein the textile housing extends within the gap to connect portions of the plastic core.

[0172] According to another aspect, the cap includes at least one bridge portion extending between these portions of the flexible joint within the plastic core.

[0173] According to another aspect, the at least one bridge portion is integrally formed with these portions of the plastic core.

[0174] According to another aspect, the hood assembly includes: a top strap; a back strap connected to the top strap at an upper connection point located on one side of the user's forehead; and a lower strap connected to the top strap and the back strap at the upper connection point. The hood assembly also includes: a first length adjustment portion that adjusts the distance between the upper connection point and the frame of the breathing interface; and a second length adjustment portion connected to the lower strap at a lower connection point located in front of the user's ear and approximately flush with the user's mouth, wherein the second adjustment mechanism adjusts the distance between the lower connection point and the frame of the breathing interface.

[0175] According to another aspect, the top strap and the rear strap are integrated into a single structure.

[0176] According to another aspect, the top strap, the rear strap, and the lower strap are integrally formed into a single structure.

[0177] According to another aspect, the first length adjustment portion includes a fabric strap with a hook-and-loop fastener mechanism.

[0178] According to another aspect, the second length adjustment section includes multiple length adjustment mechanisms.

[0179] According to another aspect, the hood assembly includes a top strap and a back strap, the back strap being connected to the top strap at an upper connection point located on one side of the user's forehead. The hood assembly also includes an upper side strap, which is connected to the top and back straps at the upper connection point and to the frame of the breathing interface. The upper side strap extends between the user's ear and eye, across the user's cheek, and toward the frame of the breathing interface. The hood assembly also includes a lower side strap, which is connected to the back strap at a rear connection point located behind the user's ear. The lower side strap extends below the user's ear, across the user's cheek, and toward the frame of the breathing interface. The hood assembly further includes a first length adjustment portion connected to the lower side strap and the frame of the breathing interface. The first length adjustment portion adjusts the distance between the lower side strap and the frame of the breathing interface.

[0180] According to another aspect, the top strap and the rear strap are integrated into a single structure.

[0181] According to another aspect, the top strap, the rear strap, the upper side strap, and the lower side strap are integrally formed into a single structure.

[0182] According to another aspect, the first length adjustment section includes a one-way adjustment mechanism.

[0183] According to another aspect, the headgear assembly also includes a second length adjustment portion connected between the upper strap and the frame of the breathing interface, wherein the second length adjustment portion adjusts the distance between the upper strap and the frame of the breathing interface.

[0184] According to another embodiment, the headgear assembly includes: a top strap; a back strap that connects to the top strap at an upper connection point located on one side of the user's forehead; and a front strap that connects to the top strap and the back strap at the upper connection point and connects to the breathing interface. The front strap extends between the user's ear and eye and toward the base of the user's nose.

[0185] According to another aspect, the top strap and the rear strap are integrated into a single structure.

[0186] According to another aspect, the top strap, the rear strap, and the front strap are integrated into a single structure.

[0187] On the other hand, the front strap extends across the front of the breathing interface and forms part of the frame of the breathing interface.

[0188] According to another aspect, the headgear assembly also includes a length adjustment portion connected between the front strap and the breathing port, wherein the length adjustment portion adjusts the distance between the front strap and the breathing port.

[0189] According to another aspect, the hood assembly includes: a top strap; a back strap that connects to the top strap at an upper connection point located on one side of the user's forehead; and a lower strap that connects to the top strap and the back strap at the upper connection point and extends substantially vertically away from the upper connection point. The lower strap is positioned in front of the user's ears. The hood assembly also includes a first length adjustment portion connected to the lower strap at a first lower connection point, the first length adjustment portion adjusting the distance between the first lower connection point and the frame of the breathing interface. The first lower connection point is positioned flush with the user's eyes, and the first length adjustment portion extends just below the eyes and across the user's cheek. The hood assembly also includes a second length adjustment portion connected to the lower strap at a second lower connection point, the second length adjustment portion adjusting the distance between the second lower connection point and the frame of the breathing interface. The second lower connection point is positioned approximately flush with the base of the user's nose, and the second length adjustment portion extends substantially horizontally across the user's cheek.

[0190] According to another aspect, the top strap and the rear strap are integrated into a single structure.

[0191] According to another aspect, the top strap, the rear strap, and the lower strap are integrally formed into a single structure.

[0192] According to another aspect, at least one of the first length adjustment portion or the second length adjustment portion includes a one-way adjustment mechanism.

[0193] According to at least one of the embodiments disclosed herein, the headgear includes a plastic core and a textile shell. The plastic core and the textile shell are formed as an integral structure by applying molten plastic material to the textile shell.

[0194] According to another aspect, the textile housing includes a first portion that covers the inward-facing surface of the headgear.

[0195] According to another aspect, the textile housing includes a second portion that covers the outward-facing surface of the headgear.

[0196] According to another aspect, the first part and the second part of the textile shell meet at the first edge and the second edge.

[0197] According to another aspect, the first part and the second part are not connected to each other at the first edge and the second edge.

[0198] According to another aspect, the textile housing includes one or more locating holes configured for engaging locating pins of a molding tool.

[0199] According to another aspect, the cap includes at least one flexible joint that allows the straps to bend.

[0200] According to another aspect, the at least one flexible joint includes a gap between portions of a plastic core, and wherein the textile housing extends within the gap to connect portions of the plastic core.

[0201] According to another aspect, the cap includes at least one bridge portion extending between these portions of the flexible joint within the plastic core.

[0202] According to another aspect, the at least one bridge portion is integrally formed with these portions of the plastic core.

[0203] According to at least one of the embodiments disclosed herein, a method of manufacturing a headgear includes: placing a textile shell within a molding tool; introducing molten plastic material into the molding tool and into contact with the textile shell; and allowing the molten plastic material to solidify on the textile shell to form a plastic core.

[0204] According to another aspect, placing the textile shell into the molding tool includes placing a first textile portion and a second textile portion into the molding tool, and introducing the molten plastic material into the molding tool includes introducing the molten plastic material between the first textile portion and the second textile portion.

[0205] According to another aspect, the method further includes: holding the end of each of the first textile portion and the second textile portion within a holding feature of the molding tool, wherein the molten plastic material is introduced at the end.

[0206] According to another aspect, the method further includes: capturing at least one edge of the textile housing between a first separable portion and a second separable portion of the molding tool.

[0207] According to another aspect, the method further includes engaging the opening of the textile housing with the locating pin of the molding tool.

[0208] According to another aspect, the method further includes fixing the textile shell within the molding tool before introducing the molten plastic material.

[0209] According to another aspect, securing the textile housing includes securing the textile housing by one or more of the following: electrostatic charge; air pressure; holding the textile housing by means of another component inserted into the molding tool; or supporting a strip of material forming the textile housing extending through the molding tool on each side of the molding tool.

[0210] According to another aspect, supporting the material strip includes supporting one end on a roller and fixing the free end relative to the molding tool.

[0211] According to another aspect, the method further includes forming a flexible joint by providing a gap in the plastic core along the length of the cap and extending the textile shell along the gap.

[0212] According to another aspect, the method further includes: extending a flexible bridge portion of the plastic material from a portion of the plastic core located on one side of the gap to a portion of the plastic core located on the opposite side of the gap through the flexible joint.

[0213] According to at least one embodiment disclosed herein, the hood includes a first strap and a second strap, wherein the first strap and the second strap cooperate to form at least one of the top strap, the back strap, and the front strap of the hood.

[0214] According to at least one of the embodiments disclosed herein, a method of manufacturing a headgear includes: placing a textile shell within a molding tool; introducing molten plastic material into the molding tool and into contact with the inside of the textile shell; and allowing the molten plastic material to solidify within the textile shell to form a plastic core.

[0215] According to another aspect, the first strap and the second strap cooperate to form a rear strap, wherein the first strap and the second strap overlap each other within the rear strap, and wherein only one of the first strap and the second strap defines a top strap.

[0216] According to another aspect, the first strap and the second strap cooperate to form a front strap, wherein the first strap and the second strap are stacked within the front strap, and wherein the first strap and the second strap individually define a corresponding one of the top strap and the rear strap.

[0217] According to another perspective, one or both of these straps are constructed from a plastic core and a textile shell, which are formed as a single structure by applying molten plastic material to the textile shell.

[0218] According to at least one embodiment disclosed herein, the headgear includes an inner core; a first outer layer defining an inner surface of the headgear facing the user in use; and a second outer layer defining an outer surface of the headgear facing away from the user in use. The first and second layers have different colors, textures, or other markings that allow for tactile or visual differentiation between the inner and outer surfaces.

[0219] According to another aspect, the first outer layer or the second outer layer comprises one of polyurethane (artificial leather), patterned polyester, wool with mesh knit, complete loops, nylon, a composite of spacer fabric and complete loops, or a composite of foam and complete loops.

[0220] According to another aspect, the edge of one or both of the first outer layer and the second outer layer extends beyond the inner core.

[0221] According to another perspective, the inner core includes internal cutouts.

[0222] According to at least one embodiment disclosed herein, the headgear includes a first strap, a second strap, and a connector for attaching the first strap to the second strap, wherein the connector is formed by overmolding onto the first strap and the second strap.

[0223] According to another aspect, the first strap and the second strap are stacked vertically within the connector.

[0224] According to another aspect, the connector includes a portion that extends between the first strap and the second strap and separates the first strap from the second strap.

[0225] According to another aspect, the connector includes a front strap portion and a rear strap portion separated by a bridge portion, wherein the bridge portion does not surround the entirety of both the first strap and the second strap.

[0226] According to another aspect, the connector includes a front band portion and a rear gusset plate.

[0227] According to another aspect, the front strap portion and the rear corner brace are separated by a bridge portion, wherein the bridge portion does not surround the entirety of both the first strap and the second strap.

[0228] According to at least one embodiment disclosed herein, the headgear strap includes an inner core, at least one outer layer at least partially surrounding the inner core, and at least one air gap located within the outer layer.

[0229] According to another aspect, the at least one air gap includes a first air gap located at one lateral edge of the strap and a second air gap located at the opposite lateral edge of the strap.

[0230] On the other hand, a portion of the inner core is exposed.

[0231] On the other hand, the conduit is positioned within the air gap.

[0232] According to another perspective, the air gap is defined by the inner core.

[0233] According to at least one embodiment disclosed herein, the headgear strap includes an inner core, at least one outer layer, and at least one conduit extending longitudinally along the strap and within the outer layer.

[0234] According to another aspect, the conduit is at least partially received within the recess of the inner core.

[0235] On the other hand, the catheter is completely encapsulated within the inner core.

[0236] According to another aspect, the at least one catheter includes a first catheter and a second catheter.

[0237] According to another aspect, the at least one conduit is defined by the core.

[0238] According to at least one embodiment disclosed herein, the headgear strap includes an inner core, at least one outer layer, and at least one reinforcing member.

[0239] On the other hand, the reinforcing member is embedded within the core.

[0240] According to another aspect, the reinforcing member is configured to keep the opposing outer layers or opposite sides of the outer layers separate from each other before the inner core is formed.

[0241] According to at least one embodiment disclosed herein, the headgear strap includes an inner core, at least one outer layer, and at least one cushioning layer.

[0242] On the other hand, the buffer layer surrounds the inner core.

[0243] On the other hand, part of the buffer layer is exposed.

[0244] According to at least one embodiment disclosed herein, the headband includes an inner core and an outer layer at least partially surrounding the inner core, the outer layer including edges. These edges are embedded within the inner core.

[0245] According to another perspective, the outer layer may consist of more than one or more than two pieces.

[0246] According to another aspect, the first piece of the outer layer is located on one side of the strap, and the second piece of the outer layer is located on the opposite side of the strap.

[0247] According to another aspect, the third piece of the outer layer is located on one edge of the strap, and the fourth piece of the outer layer is located on the opposite edge of the strap.

[0248] According to another aspect, at least two pieces of the outer layer are located on one side of the strap.

[0249] According to at least one embodiment disclosed herein, the headband includes an inner core and an outer layer, wherein the outer layer is textured.

[0250] On the other hand, the outer layer is either ridged or covered with soft material.

[0251] On the other hand, the core is textured so that it gives the outer layer a texture.

[0252] According to at least one embodiment disclosed herein, the headgear, the headgear straps or other parts have one or more features as described herein or a method of making such a headgear, headgear straps or other parts. Attached Figure Description

[0253] Preferred embodiments of the invention will be described with reference to the accompanying drawings.

[0254] Figure 1 It is a diagram showing the operational envelope representing the relationship between the force generated when the mask's sealed area is pressurized and the size range of the potential patient's headgear;

[0255] Figure 2 The force curves of the superimposed elastic headgear system are shown. Figure 1 The operational envelope;

[0256] Figure 3 The force curves superimposed with exemplary embodiments are shown. Figure 1 The operational envelope;

[0257] Figure 4 This is a graph of the force-flexure curve of an exemplary headgear device;

[0258] Figure 4.1 The exemplary headgear device is shown in its position as it is initially put on the user;

[0259] Figure 4.2 The position of an exemplary headgear device at the start of retraction is shown;

[0260] Figure 4.3 The exemplary headgear device is shown in its position at the end of wearing;

[0261] Figure 5 It is a graph including an exemplary "composite" force-flexure curve;

[0262] Figure 6 It is a force-area diagram used to maintain a sealed contact at the interface;

[0263] Figure 7 It is a three-dimensional diagram showing the relationship between head cap force, projected sealing area, and head circumference;

[0264] Figure 8A The force and elongation distributions for constant pressure treatment are shown for both elastic and inelastic headgear systems;

[0265] Figure 8B The force and elongation distributions for variable pressure therapy are shown for both elastic and inelastic headgear systems;

[0266] Figure 9 It is a side view of the nose interface with a single fixation plane;

[0267] Figure 10 This is a side view of the nose interface with two retention planes;

[0268] Figure 11 This is a side view of a full-face mask with two fixation planes;

[0269] Figure 12 This is a side view of a nasal mask with two fixation planes;

[0270] Figure 13 It is a side view of a mask with two fixed planes converging towards a single point;

[0271] Figure 13.1 This is a stability chart for different types of headgear;

[0272] Figure 13.2 A single-fixed planar interface component was demonstrated;

[0273] Figure 14 It is a side view of a full-face mask with forehead support, the full-face mask having a directional locking mechanism positioned at the connection between the hood and the mask;

[0274] Figure 15 It is a side view of a full-face mask with forehead support, the full-face mask having a directional locking mechanism positioned within a hood;

[0275] Figure 16 This is a side view of a nose mask with a directional locking mechanism located on a flat strap;

[0276] Figure 17 This is a side view of a nose mask with a directional locking mechanism featuring a flexible core design.

[0277] Figure 18 The module is shown to have an interface component configured to extend between a face mask or other interface and the rear portion of a headgear containing a directional locking device;

[0278] Figure 19 An alternative module with an interface component is shown, configured to extend between a face mask or other interface and the rear portion of a head cap containing a directional locking device spaced apart from the biasing device.

[0279] Figure 20 This is a side view of an exemplary interface component;

[0280] Figure 21 This is a side view of an exemplary full-face mask;

[0281] Figure 22 This is a side view of an exemplary nose pillow mask;

[0282] Figure 23 This is a rear perspective view of an exemplary headgear assembly positioned on a user;

[0283] Figure 24 yes Figure 23 A rear perspective view of an exemplary headgear component;

[0284] Figure 25 This is a rear perspective view of an exemplary headgear assembly located on the user;

[0285] Figure 26 An exemplary headgear component along Figure 25 Sectional view of line 26-26 in the middle;

[0286] Figure 27 An exemplary headgear component along Figure 25 Sectional view of line 27-27 in the middle;

[0287] Figure 28 An exemplary headgear component along Figure 25 Sectional view of line 28-28 in the middle;

[0288] Figure 29 This is a rear perspective view of an exemplary headgear assembly, showing portions of the exemplary headgear constructed from different material types;

[0289] Figure 30 The image shows the position where the automatic adjuster can be positioned within an exemplary headgear assembly;

[0290] Figure 31 The illustration shows the position in which the automatic adjuster can be positioned within an exemplary headgear component worn by the user;

[0291] Figure 32 An exemplary strap adjustment mechanism in an assembled form is shown;

[0292] Figure 33 It is divided into a first part and a second part. Figure 32 A plan view of an exemplary strap adjustment mechanism;

[0293] Figure 34 yes Figure 32 A perspective view of the second part of an exemplary strap adjustment mechanism;

[0294] Figure 35 This is a cross-sectional view of the directional lock in the locked and released positions;

[0295] Figure 36 The operation cycle of the cap containing the directional lock is shown;

[0296] Figure 37 This is a perspective view of an exemplary headgear assembly containing one or more directional locks;

[0297] Figure 38 This is a perspective view of an exemplary headgear assembly containing one or more directional locks;

[0298] Figure 39 It is attached to Figure 38 A side view of the attachment member on the rear portion of the exemplary headgear assembly;

[0299] Figure 40 This is a perspective view of an exemplary interface component;

[0300] Figure 41 This is a left perspective view of an exemplary interface component attached to the interface connection portion;

[0301] Figure 42 This is a side view of an exemplary interface component;

[0302] Figure 43 It is a perspective view of the frame element of the interface component attached to the interface connection part;

[0303] Figure 44 This is a front view of the frame elements of the interface component and the interface connection parts;

[0304] Figure 45 This is a front view of the frame element of the interface component attached to the interface connection part;

[0305] Figure 46 This is a right-side perspective view of an exemplary interface component attached to the interface connection portion;

[0306] Figure 47 This is a top perspective view of an exemplary interface component attached to the second part of the interface connection portion;

[0307] Figure 48 This is the top perspective view of the first component of the interface connection section;

[0308] Figure 49 This is the top perspective view of the second component of the interface connection section;

[0309] Figure 50 This is the right-hand perspective of an exemplary interface component;

[0310] Figure 51 This is a breakdown view of an exemplary interface component;

[0311] Figure 52 This is an exploded view of an exemplary interface connection portion;

[0312] Figure 53 This is an inverted exploded view of an exemplary interface connection portion;

[0313] Figure 54 This is a top view of an exemplary collapsible headgear assembly;

[0314] Figure 55 This is a rear view of an exemplary collapsible headgear assembly;

[0315] Figure 56 This is a side view of an exemplary collapsible headgear assembly;

[0316] Figure 57 An exemplary headgear assembly is shown that connects to a full-face mask type interface;

[0317] Figure 58 Demonstrates connection to the nose mask Figure 57 An example of a headgear component;

[0318] Figure 59 Demonstrates connection to the nose pillow / fork-head mask Figure 57 An example of a headgear component;

[0319] Figure 60 An exemplary headgear and interface component with a T-shaped fitting are shown;

[0320] Figure 61 An exemplary headgear and interface component without a T-shaped fitting are shown;

[0321] Figure 62 Exemplary caps and interface components with interface connection portions that can be removably attached to an interface are shown;

[0322] Figure 63 Showing the wearing Figure 62 The first position when using an exemplary interface component;

[0323] Figure 64 Showing the wearing Figure 62 The second position when referring to an exemplary interface component;

[0324] Figure 65 Showing the wearing Figure 62 The third position when referring to an exemplary interface component;

[0325] Figure 66 The perimeter of the adjustable interface component or headgear component is shown when it is at its minimum length;

[0326] Figure 67 The periphery of the adjustable interface component or headgear component at its maximum length is shown;

[0327] Figure 68A This is a cross-sectional view of the directional lock in the locked position;

[0328] Figure 68B It is in the locked position. Figure 68A A perspective cross-section of the directional lock in the image;

[0329] Figure 68C It is in an unlocked position. Figure 68A A cross-sectional view of the directional lock in the image;

[0330] Figure 68D It is in an unlocked position. Figure 68A A perspective cross-section of the directional lock in the image;

[0331] Figure 69A This is a view of the first assembly step for attaching the locking washer to the housing of an exemplary directional lock;

[0332] Figure 69B It is used to attach locking washers to Figure 69A A view of the second assembly step on the housing of an exemplary directional lock;

[0333] Figure 70A This is a view of the first assembly step for attaching locking washers to the housings of a plurality of exemplary directional locks;

[0334] Figure 70B It is used to attach locking washers to Figure 70A A view of the second assembly step on the housing of several exemplary directional locks;

[0335] Figure 71 This is a view of the assembly steps for attaching the locking washer to the housing of an exemplary directional lock;

[0336] Figure 72 This is a view of the assembly steps for attaching the locking washer to the housing of an exemplary directional lock;

[0337] Figure 73 This is a side view of an exemplary full-face mask without a forehead support.

[0338] Figure 74 This is a side view of another exemplary full-face mask without a forehead support;

[0339] Figure 75 This is a side view of an exemplary nose mask;

[0340] Figure 76 It is an exemplary headgear system having a rear portion of the headgear and two retaining planes;

[0341] Figure 77 This is another example of a headgear's front perspective view;

[0342] Figure 78 yes Figure 77 Front view of an exemplary headgear system;

[0343] Figure 79 yes Figure 77 Rear perspective view of an exemplary headgear system;

[0344] Figure 80 yes Figure 77 Front view of an exemplary headgear system and its paired nose mask device;

[0345] Figure 81 This is a front perspective view of an exemplary buffer module and frame component;

[0346] Figure 82 This is a front perspective view of the frame assembly attached to the shell of the headgear system;

[0347] Figure 83 This is a rear view of the frame assembly attached to the shell of the headgear system;

[0348] Figure 84 This is a rear view of the frame component removed from the headgear shell;

[0349] Figure 85 The functionality of the headgear device, including at least one directional locking module, was demonstrated through verification testing.

[0350] Figure 86 It is a graph showing the relationship between the elongations of an exemplary headgear device tested by force comparison; and

[0351] Figure 87 It is a force-elongation curve that shows the force fluctuations during the elongation process after the transformation.

[0352] Figure 88 This is a perspective view of a breathing cannula including the headgear device disclosed herein, which may include at least one directional locking device.

[0353] Figures 89A-89C This is a perspective view of an additional breathing cannula containing the cap devices disclosed herein, which may include at least one directional locking device and a cap quick-release device.

[0354] Figure 90 This is a perspective view of another breathing cannula including the cap device disclosed herein, which may include at least one directional locking device.

[0355] Figure 91 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include at least one directional locking device and a cap quick-release device.

[0356] Figure 92 This is a perspective view of a breathing cannula including the headgear device disclosed herein, which may include at least one directional locking device.

[0357] Figure 93 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include at least one directional locking device and a cap quick-release device.

[0358] Figure 94 This is a perspective view of a breathing cannula including the headgear device disclosed herein, which may include at least one directional locking device.

[0359] Figure 95 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include at least one directional locking device and a cap quick-release device.

[0360] Figure 96 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include a pair of directional locking devices and a pair of cap quick-release devices.

[0361] Figure 97 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include a pair of directional locking devices and a pair of cap quick-release devices.

[0362] Figure 98 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include a pair of directional locking devices and a cap quick-release device.

[0363] Figure 99 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include a pair of directional locking devices and a cap quick-release device.

[0364] Figure 100 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include a pair of directional locking devices and a pair of cap quick-release devices.

[0365] Figure 101 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include at least one directional locking device and a pair of cap quick-release devices.

[0366] Figure 102 This is a perspective view of a breathing cannula including the cap device disclosed herein, which may include a pair of directional locking devices.

[0367] Figure 103 This is a perspective view of an enlarged or controlled expiratory pressure system for use with a breathing mask in conjunction with a high-flow nasal cannula. The breathing mask may include one or more directional locking devices.

[0368] Figure 104 yes Figure 103 A perspective view of a breathing mask.

[0369] Figure 105 This is a side view of the locking component and core component of the directional lock device.

[0370] Figure 106 This is a diagram showing the edge sharpness of the locking member compared to the thickness of the locking member, illustrating the preferred operating envelope of the locking member.

[0371] Figure 107 This is an enlarged view of the locking component in the locked position.

[0372] Figure 108 It is in an unlocked position. Figure 107 A magnified view of the locking component.

[0373] Figure 109A-109C Several locking components with different possible cross-sectional opening shapes are shown.

[0374] Figure 110 It is a perspective view of a locking component with a tapered hole geometry.

[0375] Figure 111A and 111B A locking component with an alternative tapered hole geometry is shown.

[0376] Figure 112 It is a graph showing the force comparison distance of the progressive holding force distribution of the tapered hole geometry compared to the linear holding force distribution.

[0377] Figure 113A and 113B A directional locking device is shown, comprising a pair of locking members and a motion transmission element for transmitting motion between these locking members. Figure 113A The directional locking device in the unlocked position was demonstrated, and Figure 113B The directional lock device in the locked position is shown.

[0378] Figure 114A and 114B Another directional locking device is shown, comprising a pair of locking members and an alternative motion transmission element for transmitting motion between these locking members. Figure 114A The directional locking device in the unlocked position was demonstrated, and Figure 114B The directional lock device in the locked position is shown.

[0379] Figure 115 A breathing mask system including a headgear device with at least one directional locking device is demonstrated. The directional locking device is located behind the user's ear.

[0380] Figure 116 It shows possible locations for placing the directional lock device on the user.

[0381] Figure 117 The image shows possible locations for placing the directional lock behind the user's ear, with the placement area shown relative to the bones of the skull.

[0382] Figure 118A This is a side view of the headgear disclosed herein being worn by the user.

[0383] Figure 118B This is a perspective view of the headgear disclosed herein.

[0384] Figure 119 This is a cross-sectional view of the straps that form the part of the headgear that is currently disclosed.

[0385] Figure 120 This is a third-angle front view of one half of an injection molding tool configured for molding a strap component similar to the hood disclosed herein. Figure 120A yes Figure 120 3A-3A cross-sectional view, Figure 120B yes Figure 120 120B-120B cross-sectional view.

[0386] Figure 121 It is by Figure 120 An isometric view of the strapping component produced by the injection molding tool.

[0387] Figure 122 yes Figure 120 Cross-sectional view of the injection molding tool Figure 120B-120B The textile shell is placed inside.

[0388] Figure 123 yes Figure 120 A magnified view of the cross section 3A-3A of the injection molding tool, in which the textile housing is placed.

[0389] Figure 124A This is a perspective view of a second embodiment of the headgear disclosed herein.

[0390] Figure 124B This is an enlarged cross-sectional view of the size adjustment system of the second embodiment of the headgear disclosed herein.

[0391] Figure 125A yes Figure 124A and 124B A cross-sectional view of a second embodiment of the size adjustment system.

[0392] Figure 125B yes Figure 125A A plan view of the first strap of the size adjustment system.

[0393] Figure 125C This is a perspective view of the first strap that replaces the size adjustment system.

[0394] Figure 125D yes Figure 125C A cross-sectional view of the first and second straps connecting the size adjustment system.

[0395] Figure 125E yes Figure 125C A cross-sectional view of the unconnected first and second straps of the size adjustment system.

[0396] Figure 125F It is an exploded perspective view, an alternative to the resizing system.

[0397] Figure 125G yes Figure 125F A close-up exploded perspective view of the resizing system.

[0398] Figure 125H yes Figure 125A Top-down view of the first strap of the size adjustment system.

[0399] Figure 125I yes Figure 125F A cross-sectional view of the second strap of the size adjustment system.

[0400] Figure 126 This is a perspective view of a breathing device with cushioning pads, which are used... Figure 124A and 124B The size adjustment system is used for connection.

[0401] Figure 127A and 127B This is a plan view of the connections between the components of the breathing equipment.

[0402] Figure 128 This is a plan view of the headgear component with a molding fixture.

[0403] Figure 129 It is configured for forming Figure 128 A cross-sectional view of the molding tool for the headgear component.

[0404] Figure 130 This is a side view of a hood strap portion having a relatively inelastic core, a fabric shell located on at least one surface of the core, and a flexible joint located between portions of the core.

[0405] Figure 131 yes Figure 130 The headband part along Figure 130 The cross-sectional view obtained from line 14-14.

[0406] Figure 132 This is a side view of a hood strap portion having a relatively inelastic core, a fabric shell located on at least one surface of the core, and a flexible joint located between portions of the core, wherein the flexible joint includes a flexible bridge portion extending between the portions of the core.

[0407] Figure 133 yes Figure 132 The headband part along Figure 132 The cross-sectional view obtained from line 16-16.

[0408] Figure 134 A system for forming the headgear strap portion is demonstrated by using electrostatic charge to hold the fabric shell in the appropriate position within a molding die.

[0409] Figure 135 A system for forming the headgear strap portion is demonstrated by using air pressure to hold the fabric shell in the appropriate position within a molding die.

[0410] Figure 136 A system for forming the headgear strap portion is demonstrated using one or more components for holding the fabric shell in the appropriate position within a molding die.

[0411] Figure 137 A system for forming the headgear strap portion using material rollers that feed a fabric shell into a molding die is demonstrated.

[0412] Figure 138 A headgear with a first strap and a second strap is shown.

[0413] Figure 139A This is a cross-sectional view of the second strap, and Figure 139B This is a cross-sectional view of the first strap.

[0414] Figure 139C It is a cross-sectional view of an alternative strap, wherein the core of the strap includes a recessed seam configured to receive a cover layer of the strap.

[0415] Figure 139D It is a cross-sectional view of another alternative strap, wherein the core has one or more recesses occupying a large portion of the width direction of the core, and the seam of the cover layer is located within the recesses.

[0416] Figure 139E This is another cross-sectional view of an alternative strap, showing an alternative seam arrangement in which the seam of the overlay is folded over the surface of the overlay.

[0417] Figure 140A This is a view of the outer layer of the first strap, and Figure 140BThis is a view of the outer layer of the second strap.

[0418] Figure 141 A headgear with a first strap and a second strap is shown.

[0419] Figure 142A This is a cross-sectional view of the first strap, and Figure 142B This is a cross-sectional view of the second strap.

[0420] Figure 143A This is a view of the outer layer of the first strap, and Figure 143B This is a view of the outer layer of the second strap.

[0421] Figure 144 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0422] Figure 145 yes Figure 144 A cross-sectional view of a portion of the headgear.

[0423] Figure 146A yes Figure 144 The first outer view of the headgear, and Figure 146B It is the second outermost view.

[0424] Figure 147 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0425] Figure 148 yes Figure 147 A cross-sectional view of a portion of the headgear.

[0426] Figure 149A yes Figure 147 The first outer view of the headgear, and Figure 149B It is the second outermost view.

[0427] Figure 150 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0428] Figure 151 yes Figure 150 A cross-sectional view of a portion of the headgear.

[0429] Figure 152A yes Figure 150 The first outer view of the headgear, and Figure 152B It is the second outermost view.

[0430] Figure 153 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0431] Figure 154 yes Figure 153 A cross-sectional view of a portion of the headgear.

[0432] Figure 155 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0433] Figure 156 yes Figure 155 A cross-sectional view of a portion of the headgear.

[0434] Figure 157A yes Figure 155 The first outer view of the headgear, and Figure 157B It is the second outermost view.

[0435] Figure 158 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0436] Figure 159 yes Figure 158 Side view of the core of the headgear strap device.

[0437] Figure 160 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0438] Figure 161 yes Figure 160 Side view of the core of the headgear strap device.

[0439] Figure 162 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0440] Figure 163 yes Figure 162 Side view of the core of the headgear strap device.

[0441] Figure 164 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0442] Figure 165 yes Figure 164 Side view of the core of the headgear strap device.

[0443] Figure 166 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0444] Figure 167 yes Figure 166 Side view of the core of the headgear strap device.

[0445] Figure 168 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0446] Figure 169 yes Figure 168Side view of the core of the headgear strap device.

[0447] Figure 170 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0448] Figure 171 yes Figure 170 Side view of the core of the headgear strap device.

[0449] Figure 172 It is a cross-sectional view of a headgear strap device having a core and one or more outer layers.

[0450] Figure 173 yes Figure 172 Side view of the core of the headgear strap device.

[0451] Figure 174 It is a perspective view of a headgear with a first strap and a second strap.

[0452] Figure 175A yes Figure 174 A cross-sectional view of a portion of the headgear.

[0453] Figure 175B yes Figure 174 A cross-sectional view of the alternative arrangement of the straps on the headgear.

[0454] Figure 175C yes Figure 174 A cross-sectional view of an alternative arrangement of the headbands.

[0455] Figure 176 It is a perspective view of a headgear with at least a first strap and a second strap.

[0456] Figure 177 yes Figure 176 An enlarged view of a headgear, which includes a connecting device for connecting at least a first strap and a second strap.

[0457] Figure 178 Is it through Figure 177 The connection device obtained Figure 176 A cross-sectional view of a portion of the headgear.

[0458] Figure 179 It is a perspective view of a headgear with at least a first strap and a second strap.

[0459] Figure 180 yes Figure 179 An enlarged view of a headgear, which includes a connecting device for connecting at least a first strap and a second strap.

[0460] Figure 181 Is it through Figure 180 The connection device obtained Figure 179 A cross-sectional view of a portion of the headgear.

[0461] Figure 182 It is a perspective view of a headgear with at least a first strap and a second strap.

[0462] Figure 183 yes Figure 182 An enlarged view of a headgear, which includes a connecting device for connecting at least a first strap and a second strap.

[0463] Figure 184 Is it through Figure 183 The connection device obtained Figure 182 A cross-sectional view of a portion of the headgear.

[0464] Figure 185 It is a perspective view of a headgear with at least a first strap and a second strap.

[0465] Figure 186 yes Figure 185 An enlarged view of a headgear, which includes a connecting device for connecting at least a first strap and a second strap.

[0466] Figure 187 Is it through Figure 186 The connection device obtained Figure 185 A cross-sectional view of a portion of the headgear.

[0467] Figure 188 It is a perspective view of a headgear with at least a first strap and a second strap.

[0468] Figure 189 yes Figure 188 An enlarged view of a headgear, which includes a connecting device for connecting at least a first strap and a second strap.

[0469] Figure 190 Is it through Figure 189 The connection device obtained Figure 188 A cross-sectional view of a portion of the headgear.

[0470] Figure 191 It is a perspective view of a headgear with at least a first strap and a second strap.

[0471] Figure 192 yes Figure 191 An enlarged view of a headgear, which includes a connecting device for connecting at least a first strap and a second strap.

[0472] Figure 193 Is it through Figure 192 The connection device obtained Figure 191 A cross-sectional view of a portion of the headgear.

[0473] Figure 194 This is a cross-sectional view of a hood strap, which has a core and an outer layer, with one or more air gaps or voids between the outer layer and the core.

[0474] Figure 195 This is a cross-sectional view of a headband that has a core and an outer layer, with one or more conduits between the outer layer and the core.

[0475] Figure 196 This is a cross-sectional view of another type of headband, which has a core and an outer layer, with one or more conduits between the outer layer and the core.

[0476] Figure 197 This is a cross-sectional view of a headgear strap having a core and an outer layer, the core at least partially surrounding one or more conduits.

[0477] Figure 198 This is a cross-sectional view of another type of headband, which has a core and an outer layer, the core being at least partially composed of conduits surrounding one or more tubes.

[0478] Figure 199 This is a cross-sectional view of a headband that has a core and an outer layer, the core defining a pair of conduits.

[0479] Figure 200 This is a cross-sectional view of a hood strap, which has a core and an outer layer with an air gap between the outer layer and the core.

[0480] Figure 201A yes Figure 200 A cross-sectional view of the headgear strap in the first position when it is against the surface.

[0481] Figure 201B yes Figure 200 A cross-sectional view of the headgear straps in the second position against the surface.

[0482] Figure 202 This is a cross-sectional view of a hood strap having a core and an outer layer with an air gap between the outer layer and the core, wherein a portion of the core is exposed.

[0483] Figure 203 This is a cross-sectional view of another type of headband, which has a core and an outer layer with an air gap between the outer layer and the core, wherein a portion of the core is exposed.

[0484] Figure 204 This is an exploded view of the outer layer and reinforcing components of the headgear straps.

[0485] Figure 205 It includes Figure 204A cross-sectional view of the headgear straps of the outer layer and reinforcing components.

[0486] Figure 206 It is a cross-sectional view of a headband having a core, a first outer layer, a second outer layer, and one or more reinforcing or separating members that separate the outer layers before the core material is introduced.

[0487] Figure 207 It is a cross-sectional view of a headband having a core, a first outer layer, a second outer layer, and a reinforcing member encapsulated within the core.

[0488] Figure 208 It is a cross-sectional view of the headgear strap, which has a core, a buffer layer, and an outer layer.

[0489] Figure 209 It is a cross-sectional view of another headband with a core, a buffer layer, and an outer layer, wherein a portion of the buffer layer is exposed.

[0490] Figure 210 It is a side view of a portion of a headgear having several straps and connectors connecting two or more of these straps.

[0491] Figure 211 yes Figure 210 A cross-sectional view of the connector and one of these straps.

[0492] Figure 212 It is a cross-sectional view of the headband with a core and a one-piece seamless outer layer.

[0493] Figure 213 It is a cross-sectional view of a headband with a core and a one-piece outer layer with seams, wherein the edge of the outer layer is embedded in the core.

[0494] Figure 214 It is a cross-sectional view of another headband with a core and a one-piece outer layer with seams, wherein the edge of the outer layer is embedded in the core.

[0495] Figure 215 It is a cross-sectional view of a headband with a core and a pair of outer layers with a seam, wherein the edges of the outer layers are embedded in the core.

[0496] Figure 216A It is a cross-sectional view of the two-piece outer layer without the core, and Figure 216B This is a cross-sectional view of the two-piece outer layer after it has been formed in the core.

[0497] Figure 217It is a cross-sectional view of a headband with a core and a four-piece outer layer with four seams, wherein the edges of the outer layer pieces are embedded in the core.

[0498] Figure 218 It is a cross-sectional view of another headband with a core and a three-piece outer layer with three seams, wherein the edges of the outer layer pieces are embedded in the core.

[0499] Figure 219 It is a perspective view of a headband with a core and a textured outer layer, in which a portion of the outer layer has been cut away to expose the core.

[0500] Figure 220 It is a perspective view of a headband with a core and an outer layer filled with soft material, wherein a portion of the outer layer has been cut off to expose the core.

[0501] Figure 221 It is a cross-sectional view of a headband with a core and an outer layer, wherein the core gives the outer layer a textured shape.

[0502] Figure 222 It is a perspective view of a headgear with a first strap and a second strap.

[0503] Figure 223 yes Figure 222 A cross-sectional view of the first strap of the headgear.

[0504] Figure 224 yes Figure 222 A cross-sectional view of the second strap of the headgear.

[0505] Figure 225 It is a perspective view of a headgear having a first strap, a second strap, and a connection between the first strap and the second strap.

[0506] Figure 226 yes Figure 225 The headgear includes an enlarged view of the connecting part.

[0507] Figure 227 yes Figure 226 A cross-sectional view of the connection part.

[0508] Figure 228 It is a perspective view of a headgear having a first strap, a second strap, and a connection between the first strap and the second strap.

[0509] Figure 229 yes Figure 228 The headgear includes an enlarged view of the connecting part.

[0510] Figure 230 Several possible cross-sectional views of these straps within the connection section are shown.

[0511] Figure 231 yes Figure 228 A cross-sectional view of the second strap of the headgear.

[0512] Figure 232A This is a top view of the front strap and the split strap of an in-molded split hood.

[0513] Figure 232B They are linked together to form Figure 232A A perspective view of the first and second overlays of the straps of an in-mold molded forked hood.

[0514] Figure 232C They are linked together to form Figure 232A A cross-sectional view of the first and second covering layers of the straps of an in-mold molded forked cap.

[0515] Figure 233 yes Figure 232A A perspective view of an in-mold molded split hood with a partially rigid front strap.

[0516] Figure 234 yes Figure 232A A perspective view of an in-mold molded split hood, which has a rigid front strap and a partially rigid split strap.

[0517] Figure 235 yes Figure 232A A perspective view of an in-mold molded split hood with a rigid front strap and split straps.

[0518] Figure 236A It is configured for forming Figures 232A to 235 A perspective view of the mold tool for in-mold forming a forked head cap configuration.

[0519] Figure 236B yes Figure 236A Cross-sectional view of the mold tool along line 236B-236B.

[0520] Figure 236C This is a cross-sectional view of a mold tool configured to secure a fabric housing in the appropriate position within the mold tool.

[0521] Figure 236D This is a cross-sectional view of a die tool with retaining spikes that hold the fabric housing in place within the die tool.

[0522] Figure 236E yes Figure 236DA partial perspective view of the mold tool, showing the retaining spikes that hold the fabric housing in place within the mold tool.

[0523] Figure 236F yes Figure 236D A cross-sectional view of the die tool, showing a retaining spike that has pierced but not extended through the fabric housing.

[0524] Figure 236G yes Figure 236D A cross-sectional view of the die tool, showing the retaining spikes piercing the fabric housing.

[0525] Figure 237A This is a perspective view of a mold tool used to form a headgear using a woven fabric shell.

[0526] Figure 237B yes Figure 237A A cross-sectional view of the mold tool.

[0527] Figure 238 It is a cross-sectional perspective view of an alternative construction of an in-mold-molded strap with a core, a cover layer, and a rail.

[0528] Figure 239A It is a cross-sectional view of an alternative construction of an in-mold forming strap having a cavity core, a cover layer, and an in-mold forming rail edge.

[0529] Figure 239B yes Figure 239A A perspective view of the in-mold formed strap.

[0530] Figure 239C yes Figure 239A A cross-sectional view of the in-mold-molded straps when worn by a user.

[0531] Figure 240A It is a cross-sectional perspective view of an alternative construction of an in-mold forming strap with a structured core.

[0532] Figure 240B It is used for building Figure 240A A cross-sectional view of the mold tool for the structured core of the in-mold forming strap.

[0533] Figure 241A It is a perspective view of an alternative construction of an in-mold forming strap with a complex 3D shape, which has a continuously variable geometry and cross-section along its length.

[0534] Figure 241B yes Figure 241A A cross-sectional view of the in-mold forming strap along line 241B-241B.

[0535] Figure 241C yes Figure 241AA cross-sectional view of the in-mold forming strap along line 241C-241C.

[0536] Figure 242A This is a cross-sectional perspective view of an alternative in-mold bandage with an embossed brand logo.

[0537] Figure 242B This is a cross-sectional perspective view of an alternative in-mold forming strap with a laser-cut brand logo.

[0538] Figure 242C yes Figure 242B A cross-sectional perspective view of the alternative in-mold forming strap.

[0539] Figure 242D It is a cross-sectional perspective view of an alternative in-mold forming strap with a laser-cut portion that has been removed to expose the core material.

[0540] Figure 242E It is a cross-sectional perspective view of an alternative in-mold forming strap with embossed indicators and protruding indicators formed by protruding exposed core material.

[0541] Figure 242F It is a cross-sectional perspective view of an alternative in-mold forming strap with raised jigs featuring embossed characteristics.

[0542] Figure 242G It is a cross-sectional perspective view of an alternative in-mold forming strap with embossed and raised clamping features.

[0543] Figure 243A It is a cross-sectional perspective view of an alternative in-mold bandage with an overmolded brand logo.

[0544] Figure 243B It is a cross-sectional perspective view of an alternative in-mold forming strap with a raised overlay molding fixture.

[0545] Figure 243C yes Figure 243B A cross-sectional view of the alternative in-mold forming strap along line 243C-243C, featuring a raised overlay molding fixture.

[0546] Figure 244A It is a rear perspective view of a molded hood configuration with a single rear strap.

[0547] Figure 244B yes Figure 244A A cross-sectional view of the molded cap configuration along line 244B-244B.

[0548] Figure 245A It is a side perspective view of a molded headgear configuration with a lower strap connected to a top head strap by an arc-shaped connector.

[0549] Figure 245B yes Figure 245A A cross-sectional view of the molded cap configuration along line 245B-245B.

[0550] Figure 245C yes Figure 245A A side view of the molded headgear configuration.

[0551] Figure 246 It is a rear perspective view of a molded hood configuration with a rigid front strap and elastic rear and top straps.

[0552] Figure 247A It is a rear perspective view of a molded split-type headgear configuration with in-mold forming variable knit fabric.

[0553] Figure 247B yes Figure 247A A cross-sectional view of the molded cap configuration along line 247B-247B.

[0554] Figure 247C yes Figure 247A A cross-sectional view of the molded headgear configuration along line 247A-247A.

[0555] Figure 247D It is used to form Figure 247A A molding tool for molding the shape of a hat.

[0556] Figure 248A It is a side perspective view of a molded hood configuration with fully integrated bifurcated back straps and top straps.

[0557] Figure 248B yes Figure 248A A partial exploded perspective view of the molded headgear configuration.

[0558] Figure 248C yes Figure 248A A cross-sectional perspective view of the molded headgear configuration.

[0559] Figure 249A It is a side perspective view of a molded cap configuration with core material exposed and formed on the outer surface of the outer cover.

[0560] Figure 249B It is a core material recessed within an outer covering. Figure 248A A cross-sectional perspective view of the molded headgear configuration.

[0561] Figure 249C It is a cross-sectional perspective view showing a core material positioned on top of, rather than recessed into, the outer covering. Figure 248A An alternative construction to the molded headgear configuration.

[0562] Figure 250This is a side view of an exemplary in-mold hood configuration for use in conjunction with a full-face mask.

[0563] Figure 251 This is a side view of an exemplary in-mold hood configuration for use with a nose mask, the hood configuration having a lower strap located below the ears.

[0564] Figure 252 This is a side view of an exemplary in-mold hood configuration for use in conjunction with a nose pillow mask.

[0565] Figure 253 This is a side view of an exemplary in-mold hood configuration for use in conjunction with a nose mask.

[0566] Throughout the accompanying drawings, reference numerals may be repeatedly used to indicate general correspondences between reference elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of this disclosure. Detailed Implementation

[0567] Embodiments of systems, components, and methods of assembly and manufacture will now be described with reference to the accompanying drawings, wherein similar numerals refer to similar or analogous elements throughout. Although several embodiments, examples, and illustrations are disclosed below, it should be understood by those skilled in the art that the invention described herein extends beyond the specifically disclosed embodiments, examples, and illustrations, and may include other uses of the invention and their obvious modifications and equivalents. The terminology used in this specification is not intended to be interpreted in any limiting or restrictive manner merely because it is used in conjunction with the detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature alone is essential to achieving its desired properties or to practicing the invention described herein.

[0568] Certain terms may be used in the following description for illustrative purposes only and are therefore not intended to be limiting. For example, terms such as “above” and “below” refer to the directions referenced in the accompanying drawings. Terms such as “front,” “rear,” “left,” “right,” “back,” and “side” describe the orientation and / or position of portions of a component or element in a consistent but arbitrary frame of reference, which is made clear by reference to the text describing these components or elements in discussion and the associated accompanying drawings. Furthermore, terms such as “first,” “second,” “third,” etc., may be used to describe individual components. Such terms may include the words specifically mentioned above, their derivatives, and words with similar meanings.

[0569] As used herein, the term "substantially inelastic" should refer to the ability of a cap or material to resist tension relative to the load it is subjected to. Thus, a cap or material may be substantially inelastic in one direction and somewhat elastic in another. In some configurations, a cap or material is configured to be substantially inelastic in the direction of the therapeutic application load, the therapy for which the cap or material is intended. A substantially inelastic cap or material can, for example, resist tension that would compromise the seal of a breathing mask in a sealing system under normal or anticipated conditions. In a non-sealing system, a substantially inelastic cap or material can, for example, resist tension that would compromise the proper arrangement of the breathing interface in response to normal or anticipated conditions, such as hose tension or user movement. When the anticipated load is relatively low, the cap or material may have greater elasticity because the load will not be sufficient to cause tension. Conversely, if the cap and / or material is expected to be subjected to high loads, then a greater inelastic force will be required to resist tension.

[0570] Some embodiments disclosed herein relate to a headgear system and / or an interface component comprising such a headgear system, which automatically adjusts to the correct size when worn on a user's head and, once in use, transforms in nature from elastic "straightening" straps / bandages to "non-elastic" straps / bandages. In some configurations, the headgear (alone or integrated into the interface component) exhibits a relatively small headgear contraction force that tends to shorten the headgear. When attached to a face mask, the headgear and face mask cooperate to define the perimeter of the interface component, the length of which decreases toward a minimum perimeter length due to the contraction force. Although not necessarily perfectly circular, the perimeter length is often referred to as the "circumference." Thus, in this arrangement, the interface component can be positioned on the user's head and will automatically contract to the appropriate head size or very close to that appropriate head size in a manner similar to an elastic or "straightening" headgear. The retraction force is preferably sufficient to support the weight of the interface assembly at a minimum head size or a minimum useful perimeter length of the interface assembly (which may or may not coincide with the minimum perimeter length) and to at least substantially keep the interface assembly in place on the user's head. In some configurations, the retraction force may be sufficient to support the weight of a nasal cannula or other small interface, which may have, for example, a weight of about 50 grams. In other configurations, the retraction force may be between about 0.5 Newtons and about 5.2 Newtons, or between about 1 Newton and about 2.6 Newtons, or between about 1 Newton and about 1.5 Newtons, including any value or subrange within these ranges. In other configurations, the retraction force may be insufficient to support the weight of the interface and manual assistance may be required to move the interface to a sealed position on the user's face. However, preferably, once the cap is fully retracted, the cap is held in place by, for example, a directional lock. In some configurations, the retraction force is only sufficient to support the weight of the cap or is configured to support the weight of the cap.

[0571] However, in at least some configurations, the contractile force is less than the force required to maintain a seal between the mask and the user's face during treatment / use. That is, the contractile force alone is insufficient to resist the blow-off force. In some configurations, the contractile force is insufficient to resist the blow-off force across the entire range of the available perimeter length or cap size. Therefore, the cap and / or interface assembly also exhibit inelastic behavior in response to forces tending to elongate the cap or increase the perimeter length of the interface assembly. The cap and / or interface assembly may have a locking mode that can generate a locking force tending to resist expansion, elongation, or lengthening of the perimeter length. The locking force may be sufficient to resist elongation of the perimeter length in response to the blow-off force, or at least any significant elongation. In some configurations, the locking force is sufficient to resist elongation in response to the highest blow-off force expected in various uses or treatments (e.g., bilevel or CPAP, NIV, etc.). In some configurations, the locking force may be selected for one or more specific uses / treatments, but may not be applicable to all uses / treatments. In some configurations, the locking force can be selected to resist elongation in response to forces other than the blowing force (such as hose tension). This additional force can be collectively referred to here as "hose tension," and this additional resistance to elongation can be referred to here as "reserve force."

[0572] In some configurations, the cap and / or interface assembly also exhibits a yield force above which expansion or elongation of the circumferential length is permitted. Preferably, the yield force is greater than the expected blow-opening force. In some configurations, the yield force is greater than both the expected blow-opening force and the hose pull. Thus, such a cap and / or interface assembly has a reserve force. Preferably, the yield force is set low enough to allow the user to at least relatively easily apply an elongation force to the cap and / or interface assembly sufficient to exceed the yield force to allow the interface assembly to elongate and be applied to the user's head. As described above, the contraction force causes the circumferential length to decrease towards the appropriate head size.

[0573] In some configurations, the cap and / or interface assembly automatically transitions between a contraction mode, a locking mode, and a yielding mode in response to the presence or absence of an external force. For example, in the absence of an external elongation or expansion force, the cap and / or interface assembly moves toward or to the minimum perimeter length. An elongation or expansion force greater than the yield force can be applied to increase the perimeter length of the cap and / or interface assembly to a length sufficient to allow the interface assembly to be positioned on the user's head. Once the elongation or expansion force is removed (or reduced to below the contraction force), the contraction force comes into play to automatically reduce the perimeter length to or substantially reduce it to the appropriate head size, thus supporting the interface assembly on the user's head. At the start of treatment (application of a blow-off force) and / or application of a hose pull force, the cap and / or interface assembly automatically transitions to a locking mode to resist elongation of the perimeter length, or at least to resist any significant elongation or increase in the perimeter length. At the end of treatment, or at any time as desired, a force greater than the yield force can be applied to the cap and / or interface assembly to increase the perimeter length and allow the interface assembly to be removed from the user's head.

[0574] Advantageously, in this arrangement, minute adjustments to the perimeter length of the cap and / or interface assembly can be made quickly and conveniently. For example, during treatment or use, the mask can be manipulated to achieve minute adjustments to the perimeter length. For instance, in the event of a leak between the mask and the user's face, the mask can be shaken or otherwise moved to achieve a minute adjustment to the perimeter length, thereby resolving the leak. In some cases, the mask's seal can be compressed against the user's face, which allows the contractile force to automatically reduce the perimeter length. Upon release of the mask, the cap and / or interface assembly locks into or very close to the reduced perimeter length. Therefore, this configuration allows the cap and / or interface assembly to be minutely adjusted or moved to the adjusted perimeter length by small manipulations of the mask (e.g., shaking). Manipulation of other parts of the interface assembly (e.g., the cap or breathing tube / gas tubing) can similarly produce minute adjustments. Because of the nature of the human head and / or the conditions under which interface components are used, rapid and convenient micro-adjustments can significantly improve interface component performance and user satisfaction. Treatment often occurs at night and / or in other situations where the user is lying down. Therefore, the headgear may come into contact with surfaces such as pillows or beds. Movement of the user's head relative to such surfaces can cause the headgear to move, potentially altering its fit. For example, hair may move or "compress" under the headgear, which can also change the fit. The headgear straps may move up, down, or rotate on the head, potentially altering the fit. Such changes in fit can lead to leakage between the mask and the user's face. The adjustment techniques described above can allow for the automatic or minor manipulation of other parts of the mask or interface component to accommodate these changes in fit. Furthermore, the interface component can be removed and reapplied and automatically adjusted to at or very close to the appropriate headgear size. In contrast, if a conventional non-stretch headgear is moved from its desired adjustment position, such as due to error or cleaning, re-establishing that position can be difficult and time-consuming. Conventional flexible caps address the adjustment issue, but because the contraction force must withstand the highest expected blow-out and tubing pull within the smallest usable cap size, flexible caps exert relatively high pressure on the user's head, which is only partially alleviated by the application of blow-out force. This pressure can be significant for users with relatively large head sizes and low treatment pressure.

[0575] As described below with reference to a specific directional locking device, in some configurations, a certain amount of movement occurs in the cap and / or interface assembly during the transition from the resilient mode to the locked mode. For example, in some directional locking devices, the perimeter length may increase slightly during the transition from the resilient mode to the locked mode. In some cases, there is a trade-off between the increased yield force and the reduced change in perimeter length during the transition. Therefore, any reference to a particular location or perimeter length of the cap and / or interface assembly may include such a slight length change (if any) during the transition.

[0576] The following examples of the adjustment techniques described above are based on CPAP delivery. This series of graphs illustrates the typical operating envelope under which the cap system must be designed to operate, and how different current embodiments operate relative to this envelope. The envelope can include the entire CPAP treatment domain, i.e., the entire range of typical, approximate, or possible CPAP pressures and the entire range of typical, approximate, or possible head sizes. Alternatively, the envelope can include a subset of the CPAP treatment domain, such as a subset of pressures (e.g., low-pressure or high-pressure CPAP) or a subset of head (cap or interface assembly) sizes (e.g., small, medium, or large). The principles described regarding CPAP treatment can also be applied to other treatments.

[0577] Figure 1 It is a graph showing the relationship between the force generated when pressure is applied to the mask's occlusal area and the range of head size adjustments that may be encountered across the potential patient's range. The operational envelope is shown as a rectangular area defined between the minimum and maximum forces and between the minimum and maximum head sizes (circumferences).

[0578] Figure 2 The performance characteristics (force curves) of the superimposed elastic headgear system are shown. Figure 1 The operating envelope of the mask system. Clearly, for the elastic system to provide sufficient performance across the mask system's operating envelope, the elastic system must provide a force greater than the force the mask system can generate. Therefore, at low CPAP pressures, the hood provides a much greater force than is required to counteract the blow-off force. Additional force applies pressure to the user above the area defined by the mask and hood (primarily concentrated at the mask and the back of the head). The area of ​​the hood can be increased to apply force over a larger area, thereby reducing the applied pressure. However, a large hood can be annoying or uncomfortable. For example, such a large hood can retain heat over a larger area than desired.

[0579] Figure 3 This demonstrates the performance of an instance with a superimposed headgear system. Figure 1The hood system features the self-adjusting technology described above, which operates within the CPAP envelope. In the illustrated example, the force generated by the hood and / or interface components is sufficient to balance the force generated by pressurizing the closed area of ​​the hood. Essentially, the exemplary hood system automatically adjusts to the appropriate head size (circumference or perimeter length) with relatively low contractile force and then provides "on-demand" retention force matching the actual CPAP pressure. Therefore, the exemplary hood system can automatically adjust to meet the needs of any potential points within the CPAP envelope.

[0580] Figure 4 A force-flexure graph showing an example of a headgear device or an interface assembly including a headgear device is provided. The flexure axis of the graph can represent the perimeter or circumferential length of the headgear device or interface assembly. The perimeter or circumferential length can further represent the head circumference of a particular user when the headgear device or interface assembly is worn by that user. Figures 4.1-4.3 Several discrete positions are shown where a user wears (“wears”) an exemplary interface component, including a headgear device, and makes minor adjustments thereto. See also the following references. Figures 4.1-4.3 Describing the position of the sleeve Figure 4 The curve graph.

[0581] Figure 4 The graph also shows the operational envelope 10 associated with the headgear device or interface assembly, which can be related to the above regarding... Figure 1-3 The operational envelope shown and described is the same. Operational envelope 10 is shown as a rectangular region defined between the minimum and maximum forces applied to the headgear device or interface assembly due to treatment, and between the minimum and maximum head size or the perimeter / circumference length of the headgear device. Operational envelope 10 may be specific to a treatment (e.g., CPAP or bi-level PAP) or may cover multiple treatments. Similarly, head size or perimeter / circumference length may be specific to one size of the headgear device or may cover multiple sizes. Operational envelope 10 can be used to establish functional or behavioral indicators for a particular headgear device and is utilized herein to demonstrate certain features or behaviors of the disclosed embodiments.

[0582] A graph of an exemplary force-flexure curve for an exemplary headgear device or interface component (referred to as "headgear" for convenience in this discussion of graphs) is shown relative to exemplary operating envelope 10. The curve begins at or near the origin of the graph, which may represent an approximately zero force and the minimum perimeter or circumference length of the headgear (referred to as "perimeter" for convenience in this discussion of graphs). The minimum perimeter is greater than zero, but typically lies below the minimum head perimeter expected of the user or user range (taking the interface into account, if present).

[0583] like Figure 4.1As shown, in order to place the hood 100 on a user, the hood 100 is typically stretched to a length greater than the actual circumference of the user's head. Typically, the rear portion of the hood 100 is placed at the back of the user's head, and the user grasps the front portion of the hood 100 (e.g., a face mask or other interface) and applies a pull to stretch the hood 100 and move the face mask or other interface over the head and toward the face.

[0584] like Figure 4 As shown in the graph, the exemplary force-flexure curve initially rises with a steep slope, where the force increases by a large amount while the increase in circumference is relatively small. In some configurations, the force-flexure curve rises to a level above the maximum force of the operating envelope 10 before reaching the minimum circumference of the operating envelope 10. This portion of the curve may be referred to as the initial elongation portion 12a.

[0585] At a point above the maximum force of the operating envelope 10, the force-flexure curve transitions to a gentler slope, where the perimeter increases significantly while the force increase is relatively small. This gentler slope portion of the force-flexure curve may relate to the yield force of the retention mechanism of the cap 100. Preferably, the gentler slope portion of the force-flexure curve, which may be referred to as the elongation portion 12b, extends partially or entirely along the perimeter of the operating envelope 10 at or above the maximum force level of the operating envelope 10. In some configurations, the elongation portion 12b extends beyond the maximum perimeter level of the operating envelope 10. That is, the cap 100 may be configured to achieve a larger perimeter than the desired maximum head perimeter in order to allow convenient placement of the cap 100 on a user having the maximum head perimeter of the operating envelope 10 of the cap 100. In use, especially for users with a head size at the smaller end of the operating envelope 10, the headgear 100 may not be stretched to its maximum circumference during the wearing process, and in some cases, may not be stretched beyond the maximum circumference level of the operating envelope 10.

[0586] After the cap 100 has been stretched to its maximum circumference, stretched to a circumference greater than that of the operating envelope 10, or stretched to another circumference sufficient to allow it to be worn on the user, the force-flexure curve exhibited drops sharply (initial retraction portion 14a) and then transitions to a relatively gentle portion in which the circumference is greatly reduced while the change in force is relatively small. This gentle portion of the curve may be referred to as the retraction portion 14b and is partly composed of... Figure 4.2Demonstration. Preferably, in the retracted portion 14b, the circumference of the cap 100 decreases at a relatively low force level until the cap 100 reaches a circumference suitable for fitting the user's head. The cap 100 can be positioned on the user's head at this low force level (the left end of the retracted portion 14b or "fitting point 16") until treatment begins or another force is applied to attempt to elongate the cap 100.

[0587] Advantageously, this relatively low force level allows the cap 100 to be comfortable for the user. In some configurations, the retracted portion 14b of the force-flexure curve is at or below the minimum force level of the operating envelope 10. Therefore, in this arrangement, the retraction force of the cap 100 can be lower than the minimum force required or desired to resist treatment (e.g., low CPAP levels) induced in the cap 100. Thus, even at low treatment levels, the cap 100 can be configured to generate a retention force only sufficient to resist treatment-induced forces, since the minimum force level of the operating envelope 10 is above the retracted portion 14b of the force-flexure curve. In some configurations, as described below, the retracted portion 14b of the force-flexure curve may fall within the operating envelope 10. This arrangement can be described as exhibiting “composite” behavior. However, preferably, the retracted portion 14b of the force-flexure curve of the composite behavior cap remains below the maximum force level of the operating envelope 10.

[0588] When treatment begins or another elongating force is applied to the cap 100, the force-flexure curve rises relatively steeply from the mating point 16 to a point within the operating envelope 10, where the retention force of the cap 100 is balanced by the force induced by the treatment and / or other forces attempting to elongate the cap 100 (e.g., hose tension). This point may be referred to as the equilibrium mating point 18. The force-flexure curve between the mating point 16 and the equilibrium mating point 18 may have substantially the same slope as the initial elongation portion 12a. The actual location of the equilibrium mating point 18 may be anywhere within the operating envelope 10, depending on the actual force induced by the treatment and the user's actual head size. In any given case, the force applied as pressure to the user in the area of ​​the cap 100 relative to the cap size is essentially only the force required to counteract the actual force induced by the treatment. Therefore, in at least some configurations, the pressure applied to the user can be minimized for any given cap size and shape for the specific treatment level utilized. The elongated portion 12b of the force-flexure curve may be spaced above the maximum force level of the operating envelope 10 to provide a reserve force, wherein additional forces (e.g., hose tension) may be applied without elongating the cap 100. Elongation of the cap 100 may occur once a force sufficient to reach the elongated portion 12b of the force-flexure curve is applied to the cap 100. However, the cap 100 may be designed or configured to have a force-flexure curve adapted to the expected or usual therapeutic force and hose tension, or any combination thereof.

[0589] As described above, in at least some configurations, the user can manipulate the hood 100 to make minor adjustments to its circumferential length. Advantageously, this arrangement allows the user to, for example, address leaks or tighten or loosen the hood 100 (reduce its circumferential length) to a desired level by simply grasping the face mask or other interface and moving (e.g., shaking) it relative to the user's face and the rear portion of the hood 100. Figure 4.3 As shown in the image. Figure 4.3As indicated by the arrows, the mask or other interface can be moved or adjusted in multiple directions (including toward and away from the user's face) or in a rotational manner (e.g., about a vertical or horizontal / lateral axis). Movement toward the face can cause a decrease in peripheral length or tighten the hood 100 to achieve, for example, a tight fit toward an acceptable or desired fit, which may be referred to as a "tight fit." Movement away from the face can cause an increase in peripheral length or loosen the hood 100 to achieve, for example, a loose fit toward an acceptable or desired fit, which may be referred to as a "loose fit." Rotational movement about a vertical axis can cause one side of the hood 100 to tighten and the other side to remain unchanged or loosen. Rotation about a horizontal or lateral axis can cause one of the upper or lower portions of the hood 100 to tighten and the other of the upper or lower portions to loosen.

[0590] As described above, in all configurations, the retracted portion 14b of the force-flexure curve need not always be located below the minimum force level of the operating envelope 10. The cap 100 can be designed or configured to position the retracted portion 14b of the force-flexure curve within the operating envelope 10 and at a level that provides sufficient comfort to the user. In some cases, the user may desire that the cap 100 applies a certain degree of force to provide some tactile feedback that the cap 100 securely holds the interface in place, providing a feeling of comfort. For some users, this force applied by the cap 100 may fall within the operating envelope 10 of a particular treatment. Therefore, in this arrangement, under at least some conditions, the retracting force of the cap 100 may be sufficient to resist therapeutic forces at least at some lower treatment levels and / or at certain larger head sizes.

[0591] Figure 5 A graph showing an exemplary "composite" force-flexure curve is presented. For illustration, in addition to the composite force-flexure curve, an example of a force-flexure curve for an elastic headgear is also shown in the graph. The composite force-flexure curve can be combined with the above. Figure 4 The described force-flexure curves are substantially similar or identical, except that the composite force-flexure curve positions the retraction portion 14b within the operating envelope. The retraction portion 14b of the force-flexure curve divides the operating envelope into a lower portion 20 and an upper portion 22. The cap can absorb the force in the lower portion 20 below the retraction portion 14b of the force-flexure curve, thereby utilizing the retraction force of the cap, which can be provided by one or more elastic elements. The force in the upper portion 22 above the retraction portion 14b of the force-flexure curve can be absorbed by the cap's retention force, in a manner similar to that of a combined... Figure 4 In the manner described, the retaining force can be provided by one or more retaining elements (e.g., a lock).

[0592] An example of a resilient headgear force curve 15 is shown superimposed on the retraction portion 14 of a force-flexure curve. The resilient headgear force curve 15 includes upper and lower curved portions separated by a relatively small vertical distance, representing the loss or hysteresis of internal friction within the headgear. The force required to elongate the headgear is slightly greater than the headgear's retraction force. A resilient headgear exhibiting the shown resilient force-flexure curve 15 can only accommodate applied therapeutic or other forces below the force-flexure curve 15. Applied forces above the force-flexure curve 15 will cause the resilient headgear to elongate. Therefore, the force-flexure curve 15 of the resilient headgear must be positioned above the maximum force level of the operating envelope to avoid undesirable elongation under at least some conditions (e.g., high therapeutic force or effective head size). The pressure level applied to the user because of this force-flexure curve 15 is likely to be uncomfortable under at least some conditions (e.g., low therapeutic force or large head size).

[0593] In contrast, the combined force-flexure curve (or combined force-flexure curve) Figure 4 The balanced force-flexure curve (shown and described) exhibits a relatively large vertical distance between the upper portion 12b and the lower portion 14b of the curve. At least a portion of the operating envelope falls within the vertical space between the upper portion 12b and the lower portion 14b of the curve. Therefore, in the absence of therapeutic force or other elongating force, a cap exhibiting this force-flexure curve can resist relatively high forces while applying relatively low forces or pressures to the user. Furthermore, once treatment begins, the force or pressure applied to the user remains constant (if below the retracted portion 14b of the force-flexure curve in the composite arrangement) or only increases to the level required to substantially resist the applied force.

[0594] The force exerted by the interface on the headgear is typically related to the projected area of ​​the seal of that interface. Compared to a larger interface, such as a full-face mask, a smaller interface, such as a nose pillow or nose mask, seals around a smaller area and therefore generates less force. Some interfaces (e.g., nasal cannulas) may not form a seal with the user's face, and therefore the force exerted on the headgear may be primarily related to the weight of that interface. Figure 6 The graph shows the force required to maintain a tight seal between the interface and the user's face, which is related to the projected area of ​​the seal. Generally, the larger the projected area of ​​the seal, the greater the force required to maintain a tight seal between the interface and the user's face, and therefore, the greater the force the cap needs to resist. This force can be referred to as the cap's retention force.

[0595] Figure 6The graph includes two lines 24 and 26 that define the upper and lower limits of the acceptable range of retention force for interfaces with different projected sealing areas. These two lines 24 and 26 are vertically spaced apart and extend upwards from left to right with a moderate slope. The lower line 24 may represent the minimum force required or desired to maintain a seal with the user's face. The upper line 26 may represent the maximum desired force, which may be greater than the force required to maintain a seal, but is preferably low enough to maintain user comfort or avoid excessive seal collapse. The space between the lower line 24 and the upper line 26 may represent an available or target adjustment range 28 adapted to user preferences, where the lower line 24 represents an acceptable loose fit and the upper line 26 represents an acceptable tight fit. The lower line 24 may include one or more relatively short, steeply sloping upward segments representing transitions between interface types, such as a nose pillow to a nose mask and a nose mask to a full-face mask. The upper line 26 is shown as straight, but may include steep slope sections that correspond to the steep slope sections of the lower line 24 to maintain a constant target adjustment range.

[0596] Figure 6 The graph also includes a horizontal line 30 at the force level located above the target area or target region 28. This line 30 represents the force that will or is likely to cause damage to the user's skin during a relatively short period of continuous use of the particular headgear. This line 30 may be referred to as the maximum force line 30. The actual force value can vary depending on the characteristics of the particular headgear, such as the contact area or the type of material. The vertical distance between the target region 28 and the maximum force line 30 represents the tolerance 32 for adjusting the headgear force. As shown, the tolerance 32 is reduced for interfaces with a larger projected sealing area, such as full-face masks, compared to interfaces with a smaller projected sealing area, such as nose pillows or nose shields. Therefore, especially for interfaces with a larger projected sealing area, it may be desirable for the headgear to be easily or conveniently adjusted into or close to the target region 28. Conventional non-elastic headgear includes relatively coarse adjustments, such as one or more adjustable rings secured with hook and loop fasteners. Such a cap may be difficult to adjust to the target area 28, especially in environments where the wearer of the cap is not the one making these adjustments, which often occurs in settings such as hospitals.

[0597] Figure 7 A three-dimensional diagram showing the relationship between the cap force, the projected sealing area, and the perimeter. Figure 7 The curve is Figure 6 The curve and Figure 4 A combination of curves. Figure 7 The graph shows the minimum force required to form a seal between the interface and the user's face. Figure 6(Lower line 24 of target area 28). Below the minimum force line 24, the cap force may be insufficient to form or maintain a seal. Figure 7 The graph also shows the maximum force line 30, above which skin injury is likely to occur. The safe operating envelope of the cap force lies between the minimum force line 24 and the maximum force line 30. For clarity, the upper limit of the target range has been omitted.

[0598] Figure 7 The graphs also illustrate the force-flexure curves of an exemplary headgear. These curves can lie in any plane along the axis of the projected seal area to illustrate design parameters for headgear intended for use with a specific type of interface having a particular projected seal area. Headgear can also be designed to take into account both force and circumference along a segment or entirely of the axis of the projected seal area, in order to design headgear that will operate with multiple types of interfaces or (at least for a specific treatment) be universal for all types of interfaces. In some configurations, such as those by… Figure 7 As shown in the force-flexure curve, the elongated portion 12 of the force-flexure curve can be located above the maximum force line 30.

[0599] In at least some configurations, as described above, a hood exhibiting a balanced fit or a combined force-flexure curve advantageously provides retention force that falls within the safe operating envelope and, preferably, the target area. In at least some configurations, such a hood automatically adjusts to a suitable retention force within the safe operating envelope and, preferably, the target area. Therefore, insufficient or excessive tightness caused by the user or another person can be reduced or eliminated.

[0600] As described above, the exemplary headgear system performs several functions during the wearing, use, and removal of the interface or mask system. For wearing, the headgear system extends in length to allow it to be placed over the user's head. During "wearing," the headgear system retracts in length and provides sufficient force to the mask system so that the user feels the mask system is secure. Once airway pressure is applied, the headgear system "transforms" in performance from elastic or loose behavior to one with inelastic behavior. The headgear system also provides for fine adjustments to tighten or loosen the mask during use based on the user's preference. For removal, the headgear system extends in length to allow it to be removed over the user's head. A combination of one or more of these features provides a mask system requiring minimal user interaction for wearing and removal. This eliminates the possibility of misuse and can help improve the usability of the mask system. The exemplary headgear system can also mitigate the effects of overpressure on the skin by reducing the probability or even likelihood of the headgear becoming overly tight. The exemplary headgear system can improve overall treatment compliance. Another characteristic is its high degree of positional accuracy and stability. This refers to both the activity of removing and re-wearing the mask and the activity during mask use. One or more concepts are disclosed herein for achieving repeatable and stable positioning of the headgear and associated interface components on the patient's or user's head. One or more concepts are also disclosed herein for a headgear system that supports transitional behavior by providing portions that can be selectively converted to elastic or inelastic behavior, and portions that provide inelastic behavior.

[0601] Figure 8A and 8B The force distribution of constant pressure therapy and variable pressure therapy is shown, along with the associated elongation behavior of elastic and non-elastic headgear systems presented in graphical form for full-face masks. Figure 8AThis includes individual graphs of the force and elongation induced in the headgear over time under constant pressure treatment, such as CPAP at 10 cm H2O. The upper graph shows the force induced in the headgear by the combination of the applied gas pressure and the mask closure area or simply the mask area. Although the delivery pressure of the treatment is constant, the force curve includes small oscillations due to the user's breathing and the resulting changes in pressure within the mask. The lower graph shows the elongation or movement in the headgear system and therefore the mask body due to the applied force. The lower elongation graph shows two elongation lines 34 and 36. The first line 34 shows the elongation behavior of a modern, technologically advanced, elastic headgear that elongates in response to the applied force. In the example shown, the elastic headgear elongates by approximately 8 mm under CPAP pressure compared to its length without CPAP pressure. The second line 36 shows the elongation behavior of a modern, technologically advanced, inelastic headgear. As shown, this inelastic headgear exhibits very small elongation in response to the applied force.

[0602] Figure 8B Similarly, graphs are included showing the forces and elongations induced in the cap over time under the application of oscillatory or programmable pressure therapies, such as NIV or bilevel PAP. For example, the illustrated therapy varies between a pressure of approximately 5 cm H2O (e.g., expiratory positive airway pressure - EPAP) and a pressure of approximately 12 cm H2O (e.g., inspiratory positive airway pressure - IPAP). The upper graph shows the forces induced in the cap by the combination of the applied gas pressure and the mask closure area or simply the mask area. The lower graph shows the elongation or movement in the cap system and therefore in the mask body due to the applied forces. Two elongation lines 34 and 36 are shown in the elongation graph. The first line 34 shows the elongation behavior of a resilient cap of current technology that elongates and contracts as the applied force increases and decreases. In the illustrated example, the resilient cap elongates between approximately 4 mm and approximately 12 mm (corresponding to low and high pressure) in response to the variable force curve, compared to its length without CPAP pressure. A typical practice to reduce or prevent this movement is to overtighten the hood system, so that the force required to elongate the hood exceeds the combined force generated by the mask area and ventilation pressure. This practice often leads to skin damage and subsequent wound care. Line 36 illustrates the elongation behavior of a non-elastic hood with current technology, which behaves as if... Figure 8A It exhibits very little elongation, but has the limitations and disadvantages described above.

[0603] As illustrated in this example, a current-technical headgear system used with a full-face mask, and not overly tightened, will elongate in length, causing the mask body to move approximately 8 mm to approximately 12 mm during changes from peak inspiratory pressure in NIV to end-expiratory pressure or from IPAP to EPAP in bilevel ventilation. In at least some configurations, the directional locking headgear system of the present invention exhibits behavior similar to that of a non-elastic headgear, responding to a force applied in a direction that tends to elongate the headgear. However, such configurations of these directional locking headgear systems exhibit one or more of the benefits of an elastic headgear (e.g., automatic size adjustment or self-fitting) without the disadvantages associated with an associated non-elastic headgear (e.g., time-consuming and difficult to adjust). In at least some configurations, a headgear system incorporating a directional locking device provides less than approximately 4 mm of headgear elongation or mask movement during treatment in response to an applied force, compared to conditions applied to the user but without system pressure. In some configurations, the cap system including a directional locking device provides cap extension or mask movement of less than about 4 mm between high or maximum treatment pressure conditions and low or minimum treatment pressure conditions (e.g., peak inspiratory pressure and end-expiratory pressure of NIV).

[0604] The functional behavior of this exemplary cap system involves different cap elements having elongation properties in designed-specific locations, such that the elastic or stretching behavior can preferably be switched on and off as needed using one or more of the directional locking and / or directional friction mechanisms disclosed herein. This can involve different features of the cap being configured to deliver specific performance properties in specific locations. In the case of a patient interface used in respiratory applications, the location of these features can depend on the interface type and the desired number of retention planes. A retention plane can be defined as one or more planes through which forces generated in the interface components are decomposed.

[0605] For example, Figure 9 A nasal interface, such as a nasal pillow mask, nasal mask, or nasal cannula, is shown with a single retention plane. A first line extends between a mounting point on a first side of the nasal interface and a mounting point on a first side of the rear portion of the headpiece. A second line extends between a mounting point on a second side of the nasal interface and a mounting point on a second side of the rear portion of the headpiece. The first and second lines cooperate to define the single retention plane. The retention plane may extend through or near the center of the nasal interface, which may be, for example, a geometric center or a vertical center. In some configurations, the retention plane may be eccentric, such as in configurations where it may be desirable to apply a biasing force (e.g., upward or downward bias) to the nasal interface. The retention plane may generally extend from a position below or near the user's nose (e.g., slightly below that side) to a position near but slightly above the user's ear. This arrangement allows the retention plane to have an upward tilt in the anteroposterior direction.

[0606] Figure 10 Nasal interfaces with multiple (e.g., two) retention planes are demonstrated, such as nasal occipital masks, nasal masks, or nasal cannulas. (See also: Regarding...) Figure 9 As described, each retention plane is defined by lines located on each side of the interface assembly, extending between points located on the nose interface and the rear portion of the cap. Figure 10 In the arrangement, the retaining planes are offset from each other to define an angle in the front-to-back direction or from the side view. In the illustrated arrangement, a first retaining plane extends through a point located at an opposite upper portion of the nose inlet, and a second retaining plane extends through a point located at an opposite lower portion of the nose inlet. The first and second retaining planes may extend through a single point (or very close to each other) on the rear portion of the cap, or may be spaced apart on the rear portion of the cap, wherein these planes intersect (cross) each other between the nose inlet and the rear portion of the cap, or may be spaced apart between the nose inlet and the rear portion of the cap. In the illustrated arrangement, the first retaining plane is positioned at or near the upper edge of the inlet, breathing tube connector, or gas duct connector, and the second retaining plane is positioned at or near the lower edge of the inlet, breathing tube, or gas duct. In some configurations, the retaining planes may extend along a physical portion of the cap or interface assembly. However, in other configurations, the retaining planes may not extend along a physical portion of the cap or interface assembly. In other words, for example, the retaining plane may not be aligned with the headgear straps.

[0607] Other types of interface components can similarly utilize a retaining plane between the interface and the rear portion of the cap. For example, Figure 11A full-face mask with two retention planes is shown. The full-face mask shown includes an upwardly extending frame portion or T-shaped piece extending from the lower portion of the mask toward the user's forehead or from the lower portion to the forehead. In the shown arrangement, a first or upper retention plane extends between the T-shaped piece and an upper position on the rear portion of the hood. The upper retention plane may extend above the user's eyes and ears. The upper retention plane may be generally horizontal but may be slightly angled in the front-back direction. For example, the upper retention plane may be slightly angled downwards in the front-back direction to pass between the user's forehead and a center point or the rearmost point on the back of the user's head. A second or lower retention plane extends between the base portion of the mask and a lower position on the rear portion of the hood. The lower retention plane may extend between a point around the user's mouth and a point below the user's ears. The lower retention plane may be generally horizontal but may be slightly angled in the front-back direction. For example, the lower retention plane may be slightly angled upwards in the front-back direction. The upper retention plane may extend along the upper strap of the hood. The lower retention plane may generally extend along the lower strap of the headband; however, the lower strap may be curved to accommodate the user's ears, such that the lower retention plane overlaps the end portion of the lower strap, but not at least the middle portion of the lower strap. In other configurations, one or both of the upper and lower retention planes may partially or completely overlap the associated strap, may be partially or completely spaced from the associated strap, or any combination of the above.

[0608] Figure 12 A nasal mask with two fixation planes is shown. Similar to... Figure 11The full-face mask shown includes a nose shield comprising an upwardly extending frame portion or T-shaped piece extending from the lower portion of the mask toward or from the user's forehead. In the shown arrangement, a first or upper retention plane extends between the T-shaped piece and an upper position on the rear portion of the hood. The upper retention plane may extend above the user's eyes and ears. The upper retention plane may be generally horizontal but may be slightly angled in the front-back direction. For example, the upper retention plane may be slightly angled downwards in the front-back direction to pass between the user's forehead and a center point or the rearmost point on the back of the user's head. A second or lower retention plane extends between the base portion of the mask and a lower position on the rear portion of the hood. The lower retention plane may extend between a point around the user's nose and a point aligned with or below the user's ears. The lower retention plane may be generally horizontal but may be slightly angled in the front-back direction. For example, the lower retention plane may be slightly angled downwards in the front-back direction. The upper retention plane may extend along the upper strap of the hood. The lower retention plane can extend between the front and rear ends of the lower strap of the headgear. The lower strap shown can be curved to accommodate the user's ears, so that the lower retention plane does not overlap the middle portion of the lower strap. Figure 11 and 12 In any of the interface components, the lower retaining plane may pass through the inlet of the interface, the breathing tube connector, or the gas duct connector, such as passing through or near the center of the inlet or connector.

[0609] Figure 13 Alternative arrangements applicable to full-face masks or nasal masks are demonstrated, featuring two retention planes converging at a single point within the headgear system. These retention planes can be vertically spaced apart at the interface to provide some degree of stability to that interface. For example, in a full-face mask, the upper retention plane may pass under or above the user's nose, and the lower retention plane may pass near or below the user's mouth. In a nasal mask, the upper retention plane may pass above the lower side of the user's nose, and the lower retention plane may pass below the lower side of the user's nose. These retention planes may intersect at a point generally located above and / or in front of the user's ears. The interface assembly connecting these parts of the mask to the rear portion of the headgear can be separate or interconnected, allowing a single adjustment to potentially change the length of both the upper and lower parts. The length ratio of the upper and lower parts can be easily adjusted by moving the interconnected parts at the headgear connection point. The full-face mask shown does not include a forehead brace or a "T-shaped piece." However, in some configurations, a T-shaped element is available. If desired, additional hood elements or straps can be used to attach the back portion of the hood to the T-shaped element of the mask.

[0610] Figure 13.1 This is a chart identifying several general categories of headgear types based on the number and / or relative positioning of the fixation planes. The chart also identifies several interface types and provides an indication of the desirability or practicality of the resulting combinations of headgear and interface types. Because of the automatic mating of at least some of the headgear components disclosed herein, it is possible for a single headgear type to be used with multiple types of interfaces. Reference Figure 13.1 Describe examples of possible combinations. These cap types are listed from top to bottom in order of providing relatively low stability in at least some configurations (such as those that provide almost no external source of resistance to the rotation of the interface) to those that provide relatively high stability. Figure 13.1 The headwear types listed in the diagrams are not exclusive. Other headwear types can be used in conjunction with the concepts disclosed herein, including modifications and combinations of the headwear types shown.

[0611] In general, a more stable hood configuration can be general, or can provide at least an acceptable level of support for many or all interface types, or at least those interface types shown. In contrast, less stable hood configurations may not be able to provide the desired or acceptable level of support for all interface types, at least without specific measures to increase the stability of such inherently less stable configurations. Generally, larger interfaces require or benefit from hoods that provide greater stability. It is often desirable or sometimes necessary to provide at least two retention planes for larger interfaces, such as full-face hoods. For the two retention planes, it may be advantageous to separate them from each other in the vertical or height direction of the interface (e.g., at the point of attachment to the interface). Generally, the greater the spacing between these retention planes at the interface for a given hood device, the more stable the configuration. In some configurations, it may be advantageous to include an upward vector component for at least one of these retention planes.

[0612] One exemplary headgear type provides a single retaining plane. (See reference here.) Figure 9Examples of this arrangement are discussed. Generally, a single-fixation plane cap may be impractical for use with full-face mask types because it does not provide the desired level of stability to the mask. Therefore, the cap may be able to hold the mask in place and maintain a seal, but the mask may not allow for relatively easy movement and breaking of the seal, or, although operable, the interface assembly may not provide a sense of secure hold to the user. In some cases, a single-fixation plane cap may not provide an acceptable level of stability to the mask. However, it is possible that some configurations of the single-fixation plane cap can be adapted for use with full-face masks. For example, a single-fixation plane cap utilizing rigid materials and / or configurations (e.g., shape) can be adapted for use with full-face masks by providing resistance to rotation of the mask about a lateral axis. Additionally, by carefully positioning the individual fixation planes relative to the full-face mask, the single-fixation plane cap can be adapted for use with such a full-face mask, as... Figure 13.2 As shown in the following, and as per the following description Figure 13.2 As described. A single-fixation planar interface is suitable or practical for use with nasal interfaces such as nasal masks, nasal pillows, or forks and cannulas.

[0613] Figure 13.2 A single-fixation-plane interface assembly is shown, comprising a hood assembly and an interface in the form of a full-face mask. The mask shown omits the forehead brace or T-shaped element; however, a T-shaped element may be provided in other configurations. The hood assembly includes a rear portion of the hood and a hood length or perimeter adjustment portion that allows adjustment of the mask's position relative to the rear portion of the hood. The single fixation plane may extend from the mask to the rear portion of the hood, for example, at a position above the user's ears.

[0614] The forces acting on the mask can be summarized as follows: the blowing force generated by the pressure inside the mask, acting on the sealed area of ​​the user's face and attempting to move the mask away from the user's face; the head cap force acting on the mask to resist the blowing force; the force exerted by the user's face along the contact area between the mask and the user's face; and the gravitational force acting on the mass of the mask and CPAP hose. The forces exerted by the user's face can be summarized as upper forces and lower forces. The upper force can be a force located at or near the bridge of the user's nose ("bridge of nose force"), which can be the highest point or area of ​​contact in the vertical direction. The lower force can be a force located at or near the user's chin ("chin force"), which can be the lowest point or area of ​​contact in the vertical direction.

[0615] The distributed gravity can be summarized as a single-point force (“gravity”) acting at the center of gravity of the mask and CPAP hose, which can be determined by the specific size and shape of the mask. In some configurations, a single retaining plane extends vertically between the chin force and the blow-off force or passes through a point located between the chin force and the blow-off force.

[0616] The distributed blowing force can be summarized as a single-point force (“blowing force”) acting at a specific location on the mask, which can be determined by the specific size and shape of the mask and / or the shape of the user’s face. The blowing force can generally be located in the lower half of the mask’s height, such as at or near the mask’s geometric center. Assuming a generally triangular mask, the blowing force can be located approximately one-third of the height from the bottom of the mask. In some configurations, a single retaining plane extends vertically between the chin force and the blowing force, or passes through a point located between the chin force and the blowing force. Advantageously, this arrangement can provide the desired level of stability for a full-face mask with a single retaining plane. However, this arrangement can also be applied to multi-retaining-plane arrangements, where additional retaining planes provide additional stability.

[0617] The bridge of the nose area can be a sensitive anatomical region, and it may be desirable to avoid excessive force or pressure in this area. Therefore, if the bridge of the nose force is zero or minimal, the cap force may be the only force resisting the blow-off force. If the cap force passes through a point vertically above the blow-off force, the bridge of the nose force will increase, which is generally undesirable. If the cap force is too low or too close to the chin force, it may not be able to resist the blow-off force or may provide an undesirably low level of resistance to the blow-off force, thus compromising the sealing performance of the interface assembly. As described herein, preferably, the retention plane includes a directional locking device that provides appropriate resistance to the elongation of the cap in response to the blow-off force. Combined with the positioning of the retention plane as described herein, the resulting interface or cap assembly can provide a suitable level of stability for a full-face mask using a single-retention-plane type cap. For other cap assemblies described herein, appropriate stability can be achieved without over-tightening the cap, which is often the case with prior art cap devices.

[0618] Another exemplary headgear type provides two retaining planes that converge at the forward position (i.e., towards or at the interface). As combined herein... Figure 13.1As used, the term "converging" is intended to describe retaining planes that lack substantial spacing from each other at the interface or attachment point. It is possible that these retaining planes may meet at a single attachment point; however, converging headgear types may also include those in which these retaining planes are attached near or close to each other. Compared to single-retaining-plane headgear types, headgear types with two forward-converging retaining planes are suitable, or at least somewhat practical, for use with full-face masks, as the additional retaining planes provide sufficient additional stability. As described with respect to single-retaining-plane headgear types, headgear types with two forward-converging retaining planes may employ anti-rotation materials and / or configurations to provide improved performance for full-face masks. Headgear types with two forward-converging retaining planes may be suitable or practical for use with nasal interfaces such as nasal masks, nasal pillows, or forks and cannulas.

[0619] Another exemplary headgear type provides two retention planes that converge at a rearward position (i.e., away from the interface, such as at the rear portion of the headgear). A headgear type with two retention planes converging rearward can provide sufficient level of stability to be suitable or practical for use with full-face masks and nose shields. In conjunction with this... Figure 10 and 13 Examples of this type of cap, corresponding to both nose and full-face caps, are described. Cap types with two reclining retention planes converging rearward may be less practical for use with pillow or fork-type caps because these cap types typically have relatively small vertical or height dimensions. The small height of pillow and fork-type caps, at least without increasing the height dimension beyond the required height (which may be undesirable, as pillows and forks are often precisely selected by the user due to their relatively small height), limits the ability to space the attachment points of these retention planes on the cap and provide triangulation of these retention planes. Cap types with two reclining retention planes converging rearward may be impractical for use with cannulas because a sealing force is not required for the cannulas. Therefore, two-retention-plane cap types may be excessive for use with cannulas. Additionally, for the same reasons as pillows and forks, cap types with two reclining retention planes converging rearward may be impractical for use with cannulas. Cannulas generally have even smaller height dimensions than pillows and forks. However, in at least some configurations or in some cases, a type of cap with two retention planes converging backwards when used with a pillow, fork, or cannula may be practical or even desirable.

[0620] Another exemplary headgear type provides two retention planes that are separated from each other, angled, or non-parallel. In some configurations, the upper retention plane may be angled upwards in a forward-to-backward direction. The lower retention plane may be generally horizontal or angled. In other configurations, the lower retention plane may be angled in either direction. The upper retention plane may be generally horizontal or angled. Headgear types with separated / angled retention planes can provide sufficient horizontal stability to be suitable or practical for use with full-face masks and nasal masks. For the reasons mentioned above regarding headgear types with rearward convergence of the two retention planes, headgear types with separated / angled retention planes may be less practical for use with pillow or fork-head interface types, as these interface types typically have relatively small vertical or height dimensions. Similarly, for the same reasons as pillow and fork-head types described above, headgear types with separated / angled retention planes may be impractical for use with intubation cannulas.

[0621] Another exemplary type of headgear provides two retaining planes that are relatively, generally, or substantially horizontal or parallel to each other. Figure 11 and 12 Examples of this type of headgear with parallel two retention planes are shown and described. Headgear with parallel two retention planes provides sufficient horizontal stability to be suitable or practical for use with full-face masks and nasal masks. For the reasons described above regarding headgear with two retention planes converging rearward, headgear with parallel two retention planes may be less practical for use with pillow or fork-type interfaces, as these interfaces typically have relatively small vertical or height dimensions. For the reasons described above regarding headgear with two retention planes converging rearward, headgear with parallel two retention planes may be impractical for use with intubation cannulas for the same reasons as pillow and fork-type cannulas.

[0622] At least one mechanism or feature (“locking mechanism”) is positioned or otherwise configured to function along at least one of a fixation plane or fixation line, providing the ability to change the function of the hood from elongation behavior to non-elongation behavior. Along this plane, the directional locking functionality can be configured to operate as a single mechanism for a given fixation plane, or configured to preferably provide two independent locking mechanisms. A single-mechanism arrangement allows for alteration of the circumference or perimeter length of the hood or interface assembly. A two-locking-mechanism arrangement (e.g., one mechanism on each side of the hood or interface assembly) provides independent left and right fine-tuning controls for wearing a face shield or other interface. In other arrangements, more than two locking mechanisms may be provided. In such arrangements, multiple locking mechanisms may be provided on each side of the hood or interface assembly. Alternatively, these locking mechanisms may be positioned in other ways (e.g., one on each side and additional mechanisms on the top and / or rear) and may cooperate to allow adjustment of the circumference or perimeter length of the hood or interface assembly.

[0623] In some configurations, at least one locking mechanism is disposed on each side of the interface assembly between the rear portion of the face shield (or other interface) and the headgear. In some configurations, such as... Figure 14 and 15 In the full-face mask 210 shown with a forehead support or T-shaped piece, the mask 210 is connected to the rear part of the cap 220 by an upper connecting portion and a lower connecting portion, for example in the form of straps 230, located on each side of the interface assembly 200. Figure 14 and 15 These arrangements illustrate several exemplary locations where the locking feature or mechanism 240 can be located. In the illustrated arrangements, the interface component 200 includes a resilient retraction feature or mechanism 250 that works in conjunction with or in cooperation with the directional locking mechanism 240. The resilient retraction mechanism 250 and the directional locking mechanism 240 can be integrally incorporated into a module, which may be referred to herein as a directional locking module or simply as a module. In the illustrated arrangements, the directional locking mechanism 240 can be positioned at the connection between the hood 220 and the face mask 210, such as in an attachment clamping mechanism 260 (e.g., a clip) included in the face mask body, as... Figure 14 As shown. Alternatively, such as Figure 15 As shown, the directional locking mechanism can be positioned at a suitable location within the hood 220, such as between the rear portion of the hood 220 and the strap portion 230 connecting the rear portion of the hood 220 to the face mask 210. Figure 15 As shown. A similar arrangement can be used in other configurations that utilize multiple retaining planes.

[0624] In some arrangements, the directional locking mechanism or module utilizes: a lock, which is coupled to or otherwise movable relative to a portion of the interface assembly; and an adjustment member, which is coupled to or otherwise movable relative to a second portion of the interface assembly. The adjustment member can move relative to the lock to allow adjustment of the circumference or perimeter length of the hood or interface assembly. The adjustment member can be in the form of a core member, which may be, for example, a wire or filament or a strap. Under any given size adjustment of the interface assembly, a portion of the adjustment member is used to define a portion of the circumference or perimeter length, and another portion may be an excess or redundant length not utilized under a given adjustment size. The excess length will change with the change in the circumference or perimeter length of the hood or interface assembly. Accumulations of excess length can be accommodated by any suitable means, such as accommodating it within a face mask frame or an integral part within the hood system.

[0625] Figure 16 and 17 Arrangements applicable to the nasal inlet 300, such as the nasal mask 310 (with or without a forehead rest or T-shaped piece, but typically without a forehead rest or T-shaped piece), or nasal cannula are illustrated. In these arrangements, the directional locking mechanism 340 may be incorporated into, on, or operated on the flat strap 330 or mesh material, as discussed above. The use of the flat strap 330 is particularly advantageous in applications where the force vectors between the pressurized mask sealing area and the hood are misaligned. This results in situations where moments are generated, preferably sufficiently resolved through the rigidity within the hood system. This is achieved by selecting the torsional and flexural rigidity characteristics of the hood strap, the combination of which significantly improves the level of rotational stability of the mask system.

[0626] Where a straight line between the mounting point on the hood and the mounting point on the face mask 410 provides an acceptable location for the hood component or for a connecting component between the rear portion of the face mask and the hood 420, a flexible core design may be desirable, such as... Figure 17 As shown. That is, unless constrained to a modified shape, the flexible core will be in a straight line between mounting points. Therefore, the flexible core design is well-suited for use in arrangements where the straight path of the directional locking mechanism 440 (e.g., between the rear portion of the cap 420 and the face shield 410) is the desired or acceptable location of the mechanism 440.

[0627] In some arrangements, flat strap devices and flexible core devices can be used in combination, such as in applications where two or more retention planes are desired or required. For example, Figure 11 and 12 Arrangement method or Figure 14 and 15The arrangement can utilize a flat strap device along one of the upper retaining plane or the lower retaining plane, and a flexible core device along the other of the upper retaining plane or the lower retaining plane. In some configurations, the lower strap can be configured to use a flat strap device, and the strap can be configured to use a flexible core device. For example, as shown, the lower strap can have a curved shape along its length to pass below the user's ear and provide space to accommodate the ear. However, the upper strap can be generally straight along its length. In some configurations, the upper strap can utilize a flat strap device, and the lower strap can utilize a flexible core device. For example, the rear portion of the cap can be configured to position the mounting point so that the straight line between the cap mounting point and the mounting point on the face mask is properly positioned. Furthermore, as... Figure 18 and Figure 20 As shown, a flat or relatively rigid cap portion allows for flexible positioning of the directional locking mechanism, which, when connected in series with a flexible core device, contributes to torsional or bending stability along the side of the user's head.

[0628] The significant performance benefits of directional locking type hood systems or interface components emerge when used in conjunction with breathing ventilation patterns involving high constant pressure or variable pressure waveforms, such as non-invasive ventilation or bilevel ventilation, because the hood system does not elongate during use or the perimeter or circumference of the interface component remains constant. As described above, current state-of-the-art hood devices can generally be categorized as either flexible or non-flexible systems. As described, non-flexible systems can accommodate high constant pressure or variable pressure; however, such systems are prone to overstretching and are difficult and time-consuming to adjust. Current state-of-the-art flexible hood systems tend to elongate in response to high constant pressure, or elongate or recoil in response to pressure waves in a variable pressure waveform. This elongation and recoil causes the mask to circulate across the user's face, which can lead to leakage. Leakage can then cause therapeutic loss and / or mis-triggering of breathing due to changes in the resulting volume and pressure within the mask. Furthermore, the circulating movement of the mask can cause abrasion due to movement or migration of the mask across the user's face, and potentially lead to skin damage.

[0629] Figure 18 and 19Examples are shown of interface components configured to extend between a face mask or other interface and the rear portion of a hood, incorporating a directional locking device. Each of the illustrated modular devices includes a detachable clip 510 defining the connection between the face mask body and the entire hood system including the module. The module includes a resilient section 520 extending between the detachable clip 510 and the directional lock 530, which generates a contractile force tending to move the clip 510 and the directional lock 530 toward each other. The resilient section 520 can have any suitable device, such as a woven structure with one or more elastic elements. Figure 18 A variation is shown having a directional lock 530 located at the rearward end of the elastic section 520 and / or at the connection point between the module and the rearward portion of the hood. This variation positions the directional lock 530 spaced from the hood, for example, as in... Figure 15 and Figure 17 In the position shown.

[0630] Figure 19 An alternative variation is shown, positioning the directional lock 530 at a location spaced from the connection point between the module and / or the module and the rear portion of the hood. This arrangement may be referred to herein as a "remote" locking device. In some configurations, the lock can be positioned elsewhere within the hood system, such as within the rear portion of the hood, wherein a hollow conduit bridges the distance between the connection point between the module and the rear portion of the hood and the location of the directional lock. This arrangement provides a more suitable or desired location for positioning the directional lock within the hood system (e.g., like...). Figure 20 The capability at the location shown.

[0631] refer to Figure 20 The interface assembly 600 includes a face mask 610 or interface (such as a nose interface in the illustrated arrangement) and a headgear device including a rear headgear portion 620 that engages with the rear and / or upper portion of the user's head. The interface assembly 600 also includes an adjustment portion 630 that allows adjustment of the distance between the face mask 610 and the rear headgear portion 620. The adjustment portion 630 may be part of the headgear device, part of the interface, or a separate component of the interface assembly.

[0632] In the illustrated arrangement, the adjustment portion 630 includes a stretchable material 640, which can be configured to return towards its unstretched position. Therefore, the stretchable material 640 can exhibit a contraction force tending to reduce the perimeter or circumferential length of the interface assembly. In some configurations, the stretchable material 640 is a braided material comprising unstretched and stretched elements. These unstretched elements can provide stiff stops or maximum extension, and the stretched elements can provide contraction forces. In other configurations, the stretched elements 640 or other biasing devices can be positioned away from the stretchable material of the adjustment portion 630.

[0633] The illustrated interface assembly also includes a conversion locking device, such as a directional locking device. The illustrated directional locking device includes a directional lock 650, a filament core 660, and a filament guide 670 or housing (e.g., a conduit or tube). This arrangement allows the attachment position 680 between the directional lock 650 and the adjustment portion 630 and the rear cap portion 620 to be spaced apart or moved away. Additionally, the filament device allows the directional lock 650 and the adjustment portion 630 to be in a non-linear arrangement. In other words, the functional axis of the directional lock 650 can be offset or angled relative to the axis of the adjustment portion 630 and / or the retention plane of the interface assembly 600.

[0634] The filament housing 670 can extend between the directional lock 650 and the attachment position 680 between the adjustment portion 630 and the rear hood portion 620. In the illustrated arrangement, the filament housing 670 follows a complete path between the directional lock 650 and the attachment position 680 between the adjustment portion 630 and the rear hood portion 620. For example, the directional lock 650 can be located on the top headband 690 of the rear hood portion 620, and the filament housing 670 can bend upwards onto the top headband 690 at a point located behind the attachment position 680. The directional lock 650 can be located at any desired point on the top headband 690, including, for example, the side, upper, or top portion. In other configurations, the directional lock 650 can be located on other portions or at other locations on the rear hood portion 620, such as on the side or rear of the rear headband of the rear hood portion 620. This arrangement allows the directional lock 650 to be positioned at a higher point than the attachment point between the adjustment section 630 and the headband section 620 (referred to herein as "remote" installation). For example, positioning the directional lock 650 on top of the headband 690 can prevent contact with other objects (e.g., pillows) in many situations (e.g., when the user is lying face up or on their side). The specific position of the directional lock 650 can be chosen based on a variety of relevant factors, among others, such as comfort, clearance (e.g., for eyeglasses), and wire length.

[0635] In some configurations, the filament housing 670 extends beyond the directional lock 650 to accommodate excess filament 660 not used to carry the load within the interface assembly 600. The portion of the filament housing 670 extending beyond the directional lock 650 may be referred to as a accumulating portion 700 or an accumulating conduit. The portion of the filament housing 670 located between the directional lock 650 and the attachment position 680 between the adjustment portion 630 and the rear cap portion 620 may be referred to as a connecting portion 710 or a connecting conduit. Shown only as a tube herein, the filament housing 670 may be provided in other forms, such as a filament guide. The filament guide device may not completely enclose the filament, but may simply provide guide surfaces at specific discrete locations to guide the filament along a desired path.

[0636] One or more adjustment portions and / or transformation locking devices may be provided on each side of the interface assembly. These transformation locking devices located on opposite sides of the interface assembly may be integrated with each other or share components. For example, the accumulating portion of the filament housing may connect a directional lock on one side of the interface assembly to a directional lock on the other side of the interface assembly. In some configurations, a single housing may be provided on the top or rear of the interface assembly and may include two separate locking mechanisms that interact with elements (e.g., filaments) associated with the transformation locking device located on the opposite side of the interface assembly. Alternatively, separate transformation or directional lock housings associated with locking devices located on the opposite side of the interface assembly may be positioned close to each other (longitudinally or laterally adjacent) on, for example, the top or rear portion of a headgear portion.

[0637] A hood system incorporating the disclosed switching mechanism, enabling a portion of the hood to selectively switch from inelastic-type behavior to elastic-type behavior for comfortable wearing and removal, offers several user advantages. Exemplary mechanisms for achieving this behavior are disclosed herein and in the applicant's application number PCT / NZ2014 / 000074, the entire contents of which are incorporated herein by reference. In some configurations, one or more of these advantages relate to the ability to provide the user with an automatic, self-sizing, or more intuitive adjustment interaction. Additionally, in at least some configurations, a hood system incorporating the disclosed switching mechanism reduces or minimizes unwanted movement of the hood body compared to hood systems of the present technology (typically constructed of laminates of elastic material with added sewn components or sewn parts, or of elastic knitted construction). In these prior art designs, movement of the hood is likely to occur due to the interaction between the hose pull or the applied breathing pressure and the hood. This movement can lead to conditions ranging from leaks, treatment loss, and accidental changes in breathing patterns due to variations in volume and pressure, to skin abrasion or potential skin damage. To counteract this movement, the standard practice is to overtighten the hood (either by providing high elasticity in the elastic system or by manually overtightening it in an adjustable non-elastic system), so that the force required to elongate the hood is greater than the force generated by the tubing pull or the pressure applied through the mask. This excessive tightness, applying additional pressure to the user, can cause discomfort, skin irritation, or skin damage.

[0638] Due to the functionality of one or more of these automatic-fitting or transforming hood systems disclosed herein, the flexible behavior can be constrained to specific areas of the hood system (in which the flexible behavior is selectively switched on or off depending on the conditions of use), rather than the general nature of the hood. This creates the opportunity to "design" the remainder of the hood system to deliver specific performance attributes. In at least some configurations, the primary result of the designed, transforming hood system combination is to provide a behavior in which there is virtually no movement within the hood body during use.

[0639] Figure 21 and 22 For full-face masks 810 ( Figure 21 ) and nose pillow mask 812 ( Figure 22An exemplary headgear system 800 is illustrated. The indicated area 840 shows a currently preferred location where a portion with selectable elastic / inelastic functionality exists. In each application, the selectable elastic / inelastic portion 830 is positioned between the face shields 810, 812 and the rear portion 820 of the headgear system and extends along the side of the user's head. The remaining rear portion of the headgear system is ideally a relatively rigid three-dimensional (3D) structure with very little elastic behavior within the range of forces encountered during normal or desired use. To achieve this behavior, in some configurations, both the form and material construction of the headgear have a significant impact.

[0640] form

[0641] refer to Figure 23 and 24 The use of the top strap or head strap 940, as disclosed herein, and the back strap (back strap 910) that wraps around the back of the user's head, utilizes the geometry of the human head to provide repeatability of the fit and stability of the cap 900 during use. Additional design features can be added to this basic arrangement of the top strap 940 and back strap 910 to further enhance these desired properties, namely, by adding gusset plates 920 or mesh materials that link the back or lower strap 910 to the top strap 940, such as... Figure 23 and 24 As shown, the addition of the gusset plate 920 or mesh component reduces the relative movement between the rear strap 910 and the head strap 940, resulting in a more laterally stable design.

[0642] The gusset plate 920 can be attached to the rear strap 910 and the head strap 940 at any suitable location. The attachment points 930 and 960 of the gusset plate 920 on the rear strap 910 and the head strap 940 can be substantially equidistant from the contact point 950 between the rear strap 910 and the head strap 940, or they can be equidistant, or spaced at different distances from the contact point 950. In the illustrated arrangement, the distance between the location where the gusset plate 920 is attached to the head strap 940 and the contact point 950 is greater than the distance between the location where the gusset plate 920 is attached to the rear strap 910 and the contact point 950. The distance from the contact point 950 to the gusset plate 920 on the head strap 940 can be approximately twice or more than the distance from the contact point 950 to the gusset plate 920 on the rear strap 910. In the illustrated arrangement, on the head strap 940, the distance between the attachment points 960 of the gusset plates 920 on each side of the headgear 900 can be less than the distance between the attachment point 950 and the attachment point 960 of one of the gusset plates 920. That is, the length of the distance between the gusset plates 920 on the head strap 940 is less than one-third of the total length of the head strap 940. The back strap 910 and / or the head strap 940 can be continuous or discontinuous. Discontinuous sections of the back strap 910 or the head strap 940 can be connected by suitable couplings, which can be of fixed length, elastic, or adjustable.

[0643] Construction / Manufacturing

[0644] The overall form of the headgear can be produced using several different techniques. For example, the headgear can be cut from a single piece of material that is at least relatively or substantially inelastic. In other configurations, the headgear can be injection molded from a single or multiple thermoplastic or thermosetting materials. In some configurations, the headgear or head frame is constructed from a single material with variations in cross-sectional geometry, thereby providing sections with enhanced or reduced torsional and / or bending stiffness so that the headgear's profile can smoothly conform to the shape of the human head, such as... Figure 25-28 As shown. In other configurations, the hood can be constructed by co-molding or multiple-molding different materials in different parts to achieve the same or similar behavior, such as... Figure 29 As shown.

[0645] Different sections of the headgear can be constructed to have desired properties in desired parts or areas of the headgear. For example, for the section extending above the user's ears (section 1), it might be desirable to provide limited flexibility, such that bending movement about the lateral axis or torsional movement about the longitudinal axis is limited. The sections behind section 1 (sections 2 and 3) ideally conform closely to the shape of the human head. Ideally, each of sections 1, 2, and 3 exhibits relatively inelastic behavior within the range of forces normally encountered or anticipated during use. To achieve this behavior, different combinations of materials can be used. In the illustrated example, thermoplastic elastomers or thermoplastic urethane with different Shore hardness are used to achieve the desired behavior.

[0646] As described above, a headgear can include different portions with different cross-sectional dimensions, thus allowing the properties of the headgear to vary in different regions. (Reference) Figure 25-28 The diagram shows the back portion of the headgear, which generally ends above and in front of the user's ears, and is simply referred to as headgear 1000. Three vertical sections of headgear 1000 are shown. Section 1 is taken in the portion of headgear 1000 that extends above and in front of the user's ears. Section 2 is taken in the portion of headgear 1000 behind section 1 and that can generally be positioned behind the user's ears. In the arrangement shown, section 2 is located between the head strap 1010 and the gusset plate 1030. Section 3 is taken in the position behind sections 1 and 2. In the arrangement shown, section 3 is taken in the position on the rear portion of headgear 1000 that can contact the back of the user's head.

[0647] Preferably, the portion containing section 1 is relatively high to provide resistance to vertical bending loads that would attempt to move the front end of the cap 1000 vertically. In the illustrated arrangement, the portion containing section 1 has a greater height than the portion containing section 2. In some configurations, the portion containing section 3 has a greater height than the portion containing section 2. In some configurations, the portion containing section 3 has a greater height than the portion containing section 1. The portion of the cap 1000 behind the user's head (e.g., the portion containing section 3) typically exerts a greater force on the user's head due to direct resistance to the blowing force of the interface. Therefore, it may be preferable to increase the area of ​​the rear portion by providing a relatively large height to improve user comfort. In the illustrated configuration, the height at section 1 is approximately 10 mm, the height at section 2 is approximately 3 mm, and the height at section 3 is approximately 15 mm. Other dimensions may be used in other configurations. For example, these dimensions can be different, but the cap 1000 can maintain the same height ratio across any or all sections of sections 1, 2, and 3. In other configurations, these dimensions can vary by a specific number (e.g., 1 mm, 2 mm, or 3 mm) or by a proportion that is taller or shorter than the dimensions shown. In some configurations, the height of the cap 1000 changes gradually between sections 1, 2, and 3. The actual height at any point on the cap 1000 can be selected to meet appropriate performance parameters, such as bending resistance, force distribution, and fit or clearance considerations.

[0648] In some configurations, the thickness of the cap 1000 can decrease in the direction from the front to the rear. For example, the portion containing section 1 can have a thicker cross-section than the portions containing sections 2 and 3, thus making the portion containing section 1 (the front portion) more resistant to torsional loads. Similarly, the portion containing section 2 can have a thicker cross-section than the portion containing section 3. Therefore, the portion containing section 2 has greater resistance to torsional loads compared to the portion containing section 3. In some configurations, the thickness difference between the portion containing section 1 and the portion containing section 2 is greater than the thickness difference between the portion containing section 2 and the portion containing section 3. The reduced thickness of the portions containing sections 2 and 3 allows these portions to bend laterally to better conform to the specific shape of the user's head. In the illustrated arrangement, the thickness at section 1 is approximately 1.5 mm, the thickness at section 2 is approximately 1 mm, and the thickness at section 3 is approximately 0.8 mm. In other configurations, other dimensions can be used. For example, these dimensions can be different, but the cap 1000 can maintain the same thickness ratio across any or all of the sections 1, 2, and 3. In other configurations, these dimensions may vary by a specific number (e.g., 0.1 mm, 0.2 mm, or 0.3 mm) or proportionally to be thicker or thinner than the dimensions shown. In some configurations, the thickness of the cap 1000 gradually changes between sections 1, 2, and 3. The actual thickness at any point on the cap 1000 can be selected to meet appropriate performance parameters, such as torsional load resistance and lateral flexibility, to improve fit.

[0649] refer to Figure 29 As discussed above, the headgear 1100 may alternatively or additionally vary in material type throughout the headgear 1100 in order to provide different properties in different parts of the headgear 1100. Figure 29 The headgear 1100 shows three cross-sections taken at different locations within the headgear 1100, these locations being comparable to... Figure 25-28 The positions of the cap 1100 are the same or substantially the same. The portion containing section 1 can be constructed from a first material or a combination of materials, such as polypropylene. Similar to Figure 25-28The material selection for the portion containing section 1 of the headgear 1000 can take into account the desire to provide flexural resistance in the vertical direction. The material or combination of materials for the portion containing section 2 can differ from the material of one or both of the portions containing sections 1 and 3. For example, the portion containing section 2 can be constructed from a second material or combination of materials, such as a combination of thermoplastic polyurethane (TPU) and thermoplastic elastomer (TPE). The material or combination of materials for the portion containing section 3 can differ from the material of one or both of the portions containing sections 1 and 2. For example, the portion containing section 3 can be constructed from a third material or combination of materials, such as TPE. Considerations regarding the material selection for the different portions of the headgear 1100 can be related to... Figure 25-28 The considerations described in the size selection are the same or similar.

[0650] In some configurations, material selection results in cap 1100 having different hardness values ​​or hardnesses in different sections. For example, the section containing section 1 may have the highest hardness value. In some configurations, the section containing section 1 may have a hardness value of approximately 65-70 Shore D. The section containing section 2 may have a lower hardness value than the section containing section 1. In some configurations, the section containing section 2 has the lowest hardness value of the sections containing sections 1, 2, and 3. For example, the section containing section 2 may have a hardness value of approximately 70 Shore A. The section containing section 3 may have a hardness value between that of the sections containing sections 1 and 2. For example, the section containing section 3 may have a hardness value of approximately 40 Shore D. Considerations regarding the hardness selection of different sections of cap 1100 can be related to... Figure 25-28 The considerations described in the size selection are the same or similar. Variations in hardness can be achieved through material selection or other methods, such as material manipulation.

[0651] Combinations of these technologies are also possible. For example, two or more of these dimensions, materials, and stiffnesses can be selected to provide varying properties throughout the headgear. In some cases, the headgear is in a 3D form that conforms to the human head, is presented in a substantially inelastic manner, and provides stable connection points for the shift locking mechanism.

[0652] The choice of materials for one or more parts of a hood can also involve other considerations. For example, in some configurations, part or all of the hood may contain a material that exhibits almost no tendency to absorb moisture. In other configurations, part or all of the hood may contain a material that exhibits water vapor permeability. Advantageously, in such configurations, the hood can avoid or prevent moisture absorption, such as sweat absorption, or can allow moisture to move through the hood material. Either configuration can improve the user's comfort.

[0653] The headgear can be further improved by integrating a textile-based lining or padding into either or both of the inner or outer surfaces to design the texture and / or three-dimensional regularity of the headgear. In some configurations, hair traction and / or the edges of the headgear that are perceptible to the wearer are reduced or minimized. When the lining or padding is only located on one side of the headgear (inner or outer side), or when it can otherwise be distinguished between the sides (e.g., different colors on the inner and outer sides), this feature contributes to the usability of the entire device because it provides the user with a visual cue regarding the orientation of the headgear.

[0654] In some configurations, the hood may include one or more adjusters that allow adjustment of the size of the hood. For example, adjusters may be located in the strap portions of the hood to allow adjustment of the length of the strap portions. Adjusters may also be located between the strap portions to allow adjustment of the relative position of these strap portions. In some configurations, these adjusters are self-adjusting or allow self-adjustment of the hood. As used herein, self-adjusting means that the adjuster allows the hood to be adjusted from a first position (e.g., a first length or relative position) to a second position (e.g., a second length or relative position) and held in the second position without user manipulation (e.g., manual locking). In some configurations, these adjusters may include biasing elements or devices. For example, the adjuster may include biasing devices that tend to bias the strap portions in a first direction (e.g., toward a reduced length). Thus, these adjusters may simply allow the user to manipulate the hood and then automatically secure the hood in the desired position, or these adjusters may facilitate movement of the hood toward a suitable fitting position and then automatically secure the hood in that suitable fitting position. Such adjusters may include any of the change-locking devices disclosed in the applicant’s application number PCT / NZ2014 / 000074.

[0655] Figure 30 and 31Examples of positions in which the automatic adjuster can be positioned within the headgear 1200 are shown. For example, the automatic adjuster can be positioned at position 1200A, at or near the junction between the top strap or headband portion and the circumferential or upper portion located above the user's ears. The automatic adjuster can be positioned at position 1200A on each side of the headgear 1200. The automatic adjuster at position 1200A allows adjustment of the relative position of the upper portion of the headgear 1200 with respect to the headband 1210, such as in the front-back direction. Alternatively, the automatic adjuster at position 1200A can allow adjustment of the circumferential length of a portion of the headgear 1200. In other words, the length of the upper portion of the headgear 1200 can be adjusted by the automatic adjuster at position 1200A. The automatic adjuster can be positioned at position 1200B, located within the top strap or headband 1210. The automatic adjuster at position 1200B allows adjustment of the length of the head strap 1210. The automatic adjuster can be positioned at position 1200C, which is within the rear or lower portion of the hood 1200. A single automatic adjuster can be positioned within the rear portion, or the automatic adjuster can be located within each side of the lower portion of the hood 1200. Alternatively, the automatic adjuster at position 1200C can allow adjustment of the circumferential length of the lower portion of the hood 1200.

[0656] The automatic adjuster can be located in any one, any combination, or all of positions 1200A, 1200B, and 1200C, and / or elsewhere within the hood. In some configurations, the automatic adjuster is provided to allow adjustment of the rear hood portion to fit the user's head. Therefore, in addition to a shift locking mechanism, such an automatic adjuster can be located between the rear hood portion and the interface, and can be configured to adjust the relative position of the interface and the rear hood portion and apply an appropriate sealing or retaining force to the interface.

[0657] refer to Figures 32-34 The specific strap adjustment mechanism 1300 is shown. Figures 32-34 The adjustment mechanism 1300 is essentially similar to the one in the applicant's PCT application number PCT / NZ2014 / 000074. Figures 40-42 The flat strap adjustment mechanism or directional locking mechanism is shown and described. However, in some configurations, Figures 32-34 The strap adjustment mechanism 1300 includes integrated padding or lining, as described above. In some configurations, the components of the strap adjustment mechanism 1300 are constructed by molding a moldable material onto a textile-based material.

[0658] Figures 32-34An adjustable strap 1300 in an assembled form is shown, and portions of the adjustable strap are also shown separately in a plan view to illustrate the different components of the adjustment mechanism. The adjustment mechanism 1300 includes a first portion 1310 that can be coupled to a second portion 1320 in multiple adjustment positions. In some configurations, the first portion 1310 and the second portion 1320 can be infinitely adjustable within the provided adjustment range. The first portion 1310 and the second portion 1320 shown are the first and second portions of an adjustable top strap or head strap; however, the adjustable strap can be positioned in other locations, such as in combination with, for example... Figure 30 and 31 As described above, a biasing device may be provided to bias the first portion 1310 and the second portion 1320 relative to each other, for example, toward a shortened position.

[0659] Preferably, the adjustment mechanism 1300 includes a directional lock that allows the first portion 1310 and the second portion 1320 to move relative to each other in a first direction (e.g., toward the shortened position) and provides a yield force that inhibits movement in a second direction. The yield force is preferably sufficient to prevent significant movement in the second direction under normal or intended operating conditions, but can be overcome by the applied force to allow the desired adjustment of the first portion 1310 and the second portion 1320.

[0660] The first portion 1310 of the adjusting mechanism 1300 may include a substantially flat strap 1312 forming a convex portion of the adjusting mechanism 1300. The second portion 1320 of the adjusting mechanism may include a receiver or lock housing 1322 forming a concave portion of the adjusting mechanism. The lock housing 1322 may include a space 1324 for receiving a locking member, such as a locking washer. The flat strap 1312 is movable within the receiver 1322 and passes through the space 1324 for receiving the locking washer. The flat strap 1312 also passes through the locking washer. The locking washer is movable within the space 1324 of the lock housing 1322 between a release position and a locked position. In some configurations, the release position is defined by orienting the locking washer substantially perpendicular to the length direction of the flat strap 1312, and the locked position is defined by tilting the locking washer from its perpendicular orientation in the release position.

[0661] The position of the locking washer can be controlled by any suitable means, such as advancing it into a desired position from the end of the space 1324 of the lock housing 1322. For example, one end of the space 1324 of the lock housing 1322 may have a vertical surface, and the other end may have an inclined surface. When the flat strap 1312 moves toward the vertical surface, the locking washer is advanced into a vertical orientation or release position, and the flat strap 1312 is able to move relative to the lock housing 1322 with relatively low resistance. When the flat strap 1312 moves toward the inclined surface, the locking washer is advanced into an inclined orientation or locking position, and the relative movement between the flat strap 1312 and the lock housing 1322 is resisted by a yielding force. The flat strap 1312 may include a gripping portion that facilitates movement of the locking washer. Compared to the base material of the flat strap 1312, the gripping portion may be a material with higher friction or a material with higher gripping force on the locking washer.

[0662] In some configurations, each of the flat strap 1312 and the lock housing 1322 is constructed by correspondingly molding material onto a textile-based material of the first strap portion 1310 and the second strap portion 1320. In the illustrated configuration, a portion of the flat strap 1312 extends beyond the end of the textile-based material of the first strap portion 1310. In contrast, the textile-based material of the second strap portion 1320 extends beyond the lock housing 1322. Desiredly, the portion of the flat strap 1312 received within the lock housing 1322 that extends beyond the textile-based material of the first strap portion 1310 avoids interference between the textile-based materials of the first strap portion 1310 and the second strap portion 1320 within the adjustment range of the adjustment mechanism. The portion of the second strap portion 1320 extending beyond the lock housing 1322 can be configured such that the textile-based material of the first strap portion 1310 is adjacent to or overlaps with the textile-based material of the second strap portion 1320 at the maximum position or the furthest separation position of the first portion 1310 and the second portion 1320.

[0663] In some configurations, the molding material extends beyond the flat straps and / or lock housing along the textile-based material of these strap portions. For example, the molding material can be provided as a reinforcement for the textile-based material of these strap portions or as a reinforcing member of the textile-based material. Additional molding material can be provided to increase the surface area between the molding material and the textile-based material to improve the connection and / or increase the holding force therebetween. In the illustrated arrangement, the additional molding material is in the form of strips or ribs that are separated from each other in the width direction of these strap portions and generally extend in the length direction of these strap portions.

[0664] In the illustrated configuration, the strap portions 1310 and 1320 are desirablely relatively rigid in one direction (in the width direction to inhibit bending) but flexible in another direction (in the thickness direction to allow the strap to bend and conform to the user's head). This can be achieved through the geometric design of the textile-based strap portions and / or overmolding features, and / or by using different overmolding materials. In other configurations, other properties may be desired, such as the ability to adjust other positions of the mechanism. Therefore, other geometries and / or materials can be selected to provide these strap portions with the desired properties.

[0665] In some configurations, the composite strap portion is constructed through an overmolding process involving molding a moldable material 1340 onto a textile or fabric material 1350. In some configurations, the moldable material 1340 may be a plastic material. The textile or fabric material 1350 is preferably selected to provide good adhesion of the moldable material.

[0666] Textile-based materials can be placed into the model. The model can be closed, and portions of the textile-based material (e.g., edges) can be captured between separated portions (e.g., halves) of the model. Moldable materials can then be injected into the model and onto the textile-based material.

[0667] As disclosed in the applicant's patent application number PCT / NZ2014 / 000074, many different types of directional locking mechanisms can be utilized in headgear exhibiting balanced fit characteristics. In at least some configurations, the directional locking inhibits or prevents relative movement between the two parts of the headgear in a first direction, at least below the yield force of the directional lock. The directional lock also allows relative movement between the two parts of the headgear in a second direction opposite to the first direction. Preferably, movement in the second direction is allowed without resistance greater than a relatively small amount.

[0668] refer to Figure 35In some configurations, the first portion of the cap includes a core member 1400. The core member 1400 may be a filament, a filament-like element, or a thread. The second portion of the cap may include a housing 1410. The first and second portions of the cap may be coupled to any suitable part or component of the cap, which is movable relative to each other to change or adjust the circumference of the cap. The housing 1410 may be an element or receiver defining a space 1412 for receiving a locking device 1420. The housing 1410 may be a separate part from the cap, or it may be an integral part or portion of the cap. The locking device 1420 may engage the core member 1400 to inhibit or prevent movement of the core member 1400 relative to the housing 1410 in a first direction, at least below the yield force of the directional lock. The locking device 1420 may also disengage from the core member 1400 to allow movement of the core member 1400 relative to the housing 1410 in a second direction opposite to the first direction.

[0669] Locking device 1420 may include two or more locking elements movable between a first or locked position 1430 and a second or released position 1440. The illustrated locking device 1420 includes a pair of locking elements in the form of locking claws 1422. Each of the locking claws 1422 is a generally semi-cylindrical member. The locking claws 1422 cooperate to surround the core member 1400. The inner surface of each of the locking claws 1422 facing the core member 1400 is concave. Each of the locking claws 1422 includes an engaging portion 1424 that contacts the core member 1400 in the locked position 1430, such that the locking claws 1422 cooperate to engage the core member 1400. In the illustrated arrangement, the engaging portion 1424 is defined by an end portion of each of the locking claws 1422.

[0670] Each of the locking claws 1422 has its opposite end extending through the housing 1410 and includes a radially extending flange 1426. The directional lock may include a biasing device, in some configurations, which provides a tendency to orient the locking device toward a locked position or toward... Figure 35 A relatively light biasing force is applied to the left side of the page. The biasing device may include a biasing element 1428, such as a spring, that acts against the flange 1426 of the locking pawl 1422 and the end surface 1414 of the housing 1410. Preferably, the biasing device provides a light biasing force when the core member 1400 moves in a direction that tends to increase the circumference of the cap (towards...). Figure 35 When the core member moves towards the left side of the cap, the slight biasing force assists the initial movement of the locking pawl 1422 toward the locking position 1430. Figure 35When the locking claw 1422 moves to the right side of the middle position, it can move toward the release position 1440 against the biasing force of the biasing device.

[0671] As described above, housing 1410 defines a space or channel for receiving locking claws 1422 through which core member 1400 can pass. Channel 1412 may define a chamfered, angled, or tapered surface 1416 that facilitates movement of locking claws 1422 between a locked position 1430 and a released position 1440. One or more locking elements or roller elements 1418 may be positioned between each of the locking claws 1422 and housing 1410. Movement of locking claws 1422 along the longitudinal axis of housing 1410 or channel 1412 in the direction toward locked position 1430 causes roller elements 1418 to engage with tapered surface 1416, which moves roller elements 1418 and thus locking claws 1422 closer together, such that core member 1400 is clamped between locking claws 1422. Movement of the locking jaw 1422 along the horizontal axis toward the release position 1440 causes the roller element 1418 to move freely in the radial direction away from the locking jaw 1422, thereby releasing the clamping force from the locking jaw 1422 and allowing the core member 1400 to move relative to it without significant resistance. This movement of the core member 1400 can cause axial movement of the locking jaw 1422 via frictional force resisting the biasing force of the biasing device.

[0672] The core member 1400, locking claw 1422, tapered surface 1416, and / or roller element 1418 can be configured such that the directional locks apply a clamping force to the core member 1400. This clamping force substantially inhibits or prevents movement of the core member 1400 relative to the outer shell 1410 when a force below the yield force attempting to elongate the cap is applied to the core member 1400, and allows movement of the core member 1400 when a force above the yield force attempting to elongate the cap is applied to the core member 1400. As described above, this arrangement allows the cap to include one or more of these directional locks to resist normal or anticipated forces associated with treatment, while also allowing the cap to elongate for wearing or removal from the user. The directional locks can release the core member 1400 in response to a movement by which the core member 1400 attempts to retract the cap, allowing the core member 1400 to move relative to the outer shell 1410 with relatively little resistance. This arrangement allows the cap to include one or more of these directional locks for retraction to fit the head size of a particular user. The retraction force that tends to retract the cap can be provided by any suitable method or mechanism, including manual retraction or automatic retraction caused by the cap's elastic device or elastic element.

[0673] Figure 36The diagram illustrates the operational cycle of a headgear containing a directional lock (such as the directional lock described above, any other directional lock described herein or included by reference, or any other suitable directional lock). In the operational cycle diagram, the upward component of the arrow represents the elongation of the headgear (an increase in the circumference of the headgear), and the downward component of the arrow represents the contraction of the headgear (a decrease in the circumference of the headgear). The arrows point towards... Figure 36 The component on the right side of the arrow represents the elongation movement of the cap, and the component pointing to the left represents the retraction movement of the cap.

[0674] Figure 36 The description refers to the structure of the directional lock just described above; however, the basic concepts highlighted in this specification are equally applicable to many or all other directional locks described or included herein. The central arrow above indicates the movement of the core member in a direction tending towards elongation of the cap due to a force applied above the yield force of the directional lock. Therefore, the core member can slide through the locking claws, which are clamped against the core member by the interaction of the roller elements and the tapered surface of the channel in the housing. This force can be applied when applying or removing the cap.

[0675] The next arrow, pointing clockwise, indicates the change in direction of the core component from elongation to retraction. This change in direction results in the release of the clamping force on the core component.

[0676] The next arrow, moving clockwise, indicates the retraction movement of the core component. Therefore, movement of the core component allows the locking pawl to move, preventing the roller element from being forced into the narrow section of the tapered surface. This allows for a relatively free retraction movement of the core component. This movement allows the cap to retract to fit a specific user or to retract to its minimum circumference when not in use.

[0677] The next arrow in the clockwise direction indicates a change in direction for the core component from retraction to extension. This change in direction results in the application of a clamping force to the core component. In each case of a change in direction, the core component may undergo some movement before the change in clamping force or the positional change of the directional lock occurs or is fully achieved. This cycle can repeat as the cap is applied to or removed from the user. In some cases, this cycle may occur when the user makes fine adjustments to the cap.

[0678] Figure 37-53A headgear assembly 1500 including one or more directional locks 1510 is shown. The shown headgear assembly 1500 is configured for attachment to a portion of an interface 1520. Specifically, the shown headgear assembly 1500 includes a rear portion 1530, an interface connection portion 1540, and a length or circumference adjustment portion 1550 inserted between the rear portion 1530 and the interface connection portion 1540. The rear portion 1530 is configured to contact the rear of the user's head during use. The interface connection portion 1540 is configured to attach to the interface 1520 during use, such that the headgear assembly 1500 can support the interface 1520 in a proper position on the user's face. The length or circumference adjustment portion 1550 is configured to allow adjustment of the position of the interface connection portion 1540 relative to the rear portion 1530 during use, thereby allowing the headgear assembly 1500 to be adjusted to the head size of a particular user. Therefore, the length or circumference adjustment portion 1550 allows for adjustment of the circumference or perimeter of the cap so that the cap assembly 1500 can fit the head size of a particular user.

[0679] Although shown and described as a headgear assembly 1500, in some configurations, these portions of the shown headgear assembly 1500 may be incorporated into any other suitable portion of the entire interface assembly. For example, the interface connection portion 1540 may include a part or portion of the interface that is detachable from and connectable to the headgear assembly 1500. The length or circumference adjustment portion 1550 may include a part or portion of the interface that is detachable from and connectable to the headgear assembly 1500, or a part or portion of the headgear assembly 1500 that is detachable from and connectable to the interface 1520. However, advantageously, and as further described above, the shown headgear assembly 1500 may include a self-contained, self-fitting headgear unit that exhibits balance-fit characteristics and can be attached to at least one and possibly multiple types of interfaces. Thus, in at least some configurations, one type of the shown headgear assembly 1500 can be used with multiple types of interfaces. Therefore, retailers can stock a smaller number of unique products while providing the same interface options. In addition, users can utilize a single headgear assembly and switch interfaces as desired without manually adjusting the headgear assembly when changing from one interface to another.

[0680] In the illustrated arrangement, the rear portion 1530 of the cap includes at least one strap portion 1560 that contacts the user's head. Preferably, at least one strap portion 1560 contacts the rear portion or back of the user's head, such that at least one strap portion 1560 can resist forces induced in the cap assembly 1500 by pressure applied to the interface during treatment. In some configurations, the strap portion 1560 extends generally or substantially laterally around the rear of the user's head and has an end on each side of the user's head. Each end can be attached to another portion of the cap assembly 1500, such as the circumference adjustment portion 1550.

[0681] In some configurations, at least one strap portion 1560 includes a first strap portion and a second strap portion. The first strap portion may be a rear strap portion 1562 extending around the back of the user's head, and the second strap portion may be a top strap portion or an upper strap portion 1564 extending above the user's head. The rear strap portion 1562 may be positioned to contact a portion corresponding to one or both of the occipital or parietal bones of the user's head. The top strap portion 1564 may be positioned to contact a portion corresponding to one or both of the parietal or frontal bones of the user's head. Thus, the top strap 1564 may be configured as either a top head strap or a forehead strap, as sometimes characterized in the prior art. Other suitable devices may also be used.

[0682] Preferably, the back portion 1530 of the hood engages with the user's head and provides a relatively stable platform for connecting interfaces, such as the interface connection portion 1540 and the circumference adjustment portion 1550. Thus, in at least some configurations, the back portion 1530 is substantially inelastic, such that the back portion maintains its shape and effective length in response to applied forces within a desired or anticipated range. In some configurations, the back portion 1530 may include a layer of relatively rigid material (such as a plastic material) bonded to one or more layers of fabric material. Preferably, the fabric layer is provided at least on the surface of the rigid material layer that contacts the user. In some configurations, the fabric layer is provided on each side of the rigid material layer. Furthermore, in some configurations, the rigid material layer may be formed between these material layers, such as by injection molding the rigid material into a space within a mold located between two material layers. Examples of such a hood and methods of manufacturing such a hood are disclosed throughout by reference to U.S. Provisional Application No. 62 / 050,925, which is incorporated herein by reference.

[0683] The circumference adjustment portion 1550 may include a pair of adjustment elements 1552, one of which is positioned on each side of the hood assembly 1500. Specifically, each of the adjustment elements 1552 may be engaged with one side of the rear portion 1530 of the hood and one side of the interface connection portion 1540. The adjustment element 1552 may be engaged at or near the joint between the top strap 1564 and the rear strap 1562. In the illustrated arrangement, the adjustment element 1552 is engaged with a forward extension of the rear portion 1530 of the hood, which extends forward from the joint between the top strap 1564 and the rear strap 1562. The adjustment element 1552 is adjustable in length between a retracted length and an extended length. In some configurations, the adjustment elements 1552 cooperate to provide full or substantially full adjustment of the circumference of the hood assembly 1500. Each of the adjusting elements 1552 may further include a resilient element or biasing device that biases the adjusting element 1552 toward one of the retracted length or the extended length. Preferably, the adjusting element 1552 is biased toward the retracted length, such that the cap assembly 1500 is biased toward its minimum circumference. This arrangement allows the cap assembly 1500 to be extended and then automatically retracted under the biasing force of the resilient element or other biasing device of the adjusting element 1552 to fit a particular user. Additionally, preferably, the adjusting element 1552 defines a hard stop or maximum extension length to limit the extension of the cap 1500 and define the maximum circumference of the cap 1500.

[0684] In some configurations, the adjusting element 1552 includes a knitting element 1554 that can be extended or retracted in length. The knitting element 1554 may include one or more elastic elements parallel to the knitting element 1554. These elastic elements may be separate from or included within the knitting element 1554. In some configurations, these elastic elements are housed within the internal space between the filaments of the knitting element 1554. Suitable examples of knitting elements are associated with the applicant's patent application number PCT / NZ2014 / 000074. Figures 46-54 As described above. However, other suitable constructions or arrangements may also be used. Alternatively, the elastic element or biasing element may be located within the interface connection portion and may interact with the core member to pull the core member into the interface connection portion.

[0685] The interface connection portion 1540 of the headgear assembly 1500 may extend between a pair of adjustment elements 1552 constituting the circumference adjustment portion 1550. In some configurations, the interface connection portion 1540 is directly coupled to the adjustment element 1552. As described above, the interface connection portion 1540 may facilitate the connection of the headgear assembly 1500 to the interface 1520. However, the interface connection portion 1540 may also accommodate at least a portion of one or more directional locks 1510. In the illustrated arrangement, a pair of directional locks 1510 are provided, one of which is associated with one of the pair of adjustment elements 1552. A portion of the directional lock 1510 (e.g., housing 1512) may be located at each end of the interface connection portion 1540. In some configurations, the core member 1570 associated with each of the directional locks 1510 is coupled to the rear portion 1530 of the cap, extends along or through the adjustment element 1552, through the housing 1512 of the directional lock 1510, and into the collection space 1542 of the interface connection portion 1540. The housing 1512 of the directional lock 1510 may include one or more members or elements (e.g., locking washers or locking claws) that interact with the core member 1570 to selectively allow the cap assembly 1500 to retract or lock the cap assembly 1500 within a specific circumference, and to inhibit or prevent the cap 1500 from elongating at least under forces below the yield force provided by the directional lock 1510. Further operational details of the directional lock 1510 are described above and in the applicant's patent application number PCT / NZ2014 / 000074.

[0686] In some configurations, one or both of the core member 1570 and the adjustment element 1552 are secured to the rear portion 1530 of the hood by encapsulating the core member 1570 and / or the adjustment element 1552 within the hood rear portion 1530. For example, the core member 1570 and / or the adjustment element 1552 can be positioned within a mold, and a rigid material portion of the hood rear portion 1530 can be formed by injection molding, such that the rigid material portion encapsulates the core member 1570 and / or the adjustment element 1552. In the illustrated arrangement, the end portions of the adjustment element 1552 and the end portions of the core member 1570 are encapsulated within the rigid material portion of the hood rear portion 1530. However, other suitable arrangements may also be used.

[0687] In some configurations, the adjustment element 1552 includes an end cap portion 1556 connecting the braided element 1554 and the elastic element. The end cap portion 1556 can be applied to the end of the adjustment element 1552 via an overmolding process. Specifically, the braided element 1554 and the elastic element can be placed in a mold, and the end cap portion 1556 can be formed by injection molding over the end portions of the braided element 1554 and the elastic element. In some configurations, the braided element 1554 and / or the elastic element are held in a stretched state during the overmolding process. In some configurations, the adjustment element sub-assembly is then attached to the back portion 1530 of the cap, such as via the overmolding process described above. Thus, the end cap portion 1556 of the adjustment element 1552 can be encapsulated by the back portion 1530 of the cap.

[0688] The end cap portion 1556 of each of the adjusting elements 1552, opposite to the rear portion 1530 of the cap, can be attached to the interface connection portion 1540 by any suitable means. In the illustrated configuration, the end cap portion 1556 of the adjusting element 1552 is attached to a collar or socket 1580, which in turn is attached to the interface connection portion 1540. For example, the end cap portion 1556 may be press-fitted or otherwise secured within the socket 1580. The socket 1580 may include a neck portion 1582 that spacees a retaining portion 1584 of the socket 1580 from the body 1586. The neck portion 1582 may extend through an opening 1544 in the interface connection portion 1540, and the retaining portion 1584 of the socket 1580 may prevent the socket 1580 from separating from the interface connection portion 1540. In some configurations, the retaining portion 1584 of the socket 1580 can be integrated with the housing 1512 of the directional lock 1510.

[0689] In some configurations, the interface connection portion 1540 may be composed of multiple components that cooperate to define a collection space. These components may also cooperate to define a space 1590 for receiving the housing 1512 of each directional lock 1510. In the illustrated arrangement, the interface connection portion 1540 includes a first component 1592 and a second component 1594, which are connectable to define a collection space 1596 and a pair of spaces 1590 for receiving the housing 1512 of the directional lock 1510. The first component 1592 and the second component 1594 may correspondingly be an upper and lower component. In other arrangements, the first component 1592 and the second component 1594 may be, for example, a front and a rear component. The provision of the separator facilitates the assembly of the housing 1512 of the directional lock 1510, the core member 1570 of the directional lock 1510, and the socket 1580 leading to the interface connection portion 1540.

[0690] The collection space 1596 of the interface connection portion 1540 is configured as an accumulator to receive the end portions of the core member 1570, which, in the illustrated arrangement, are excess or inactive portions and do not form the operating portion of the core member 1570. That is, the portion of the core member 1570 located between the mounting point at the rear portion 1530 of the cap and the mounting point at the housing 1512 of the directional lock 1510 (or at the locking element of the directional lock) is active and forms part of the cap's circumference. When a force is applied that tends to elongate the cap, these portions of the core member 1570 are placed under tension. The lengths of the active and inactive core member portions will change with adjustments to the cap assembly 1500 or momentary changes in circumference. Therefore, the collection space 1596 provides a location to accumulate and protect the inactive portions of the core member 1570.

[0691] Desiredly, the length of the collection space 1596 is at least as large as the extension distance (the difference between the extended length and the retracted length) of one of the adjusting members 1552. In other words, the extension distance of the adjusting member 1552 is preferably less than or equal to the length of the collection space 1596, such that there is sufficient space in the collection space 1596 for an excess core member portion having sufficient length to allow the adjusting member 1552 to move from the retracted position to the extended position, while at least some of the excess core member 1570 length remains within the collection space 1596, such that the core member 1570 is not completely pulled through the housing 1512 of the directional lock 1510. In some configurations, the collection space 1596 may include a separation space or channel for each of the core members 1570.

[0692] A portion of the interface connection portion 1540 may be configured to connect to or a portion of the interface 1520. In some configurations, the interface connection portion 1540 may be selectively or removably connected to the interface 1520. In the illustrated arrangement, the portion of the interface connection portion 1540 defining the collection space 1596 is configured to be received within a receiving channel 1522 of the interface member 1524. The receiving channel 1522 may be defined by the interface member 1524 and configured to receive the interface connection portion 1540 in a snap-fit ​​manner as a semi-cylindrical space. The central portion of the interface connection portion 1540 defining the collection space 1542 may be generally cylindrical or cylindrical in external shape. In the illustrated arrangement, the central portion of the interface connection portion 1540 is curved along its length.

[0693] Interface member 1524 can be any part of interface 1520. For example, interface member 1524 can be a relatively rigid part of interface 1520, such as a housing or frame element 1526. In the illustrated arrangement, interface member 1524 is a frame element 1526 that can directly or indirectly support mask seal 1528, cushion 1532, or other interface elements. Frame element 1526 (or another part of the interface) can support a conduit connector, such as a bend 1534. In some configurations, interface member 1524 can be configured to support several different types of mask seal 1528, cushion 1532, or other interface elements. In some configurations, interface member 1524 can be integrated with or designed for use with a particular mask seal 1528, cushion 1532, or other interface element, and different interface members 1524 can be integrated with or associated with each type of mask seal 1528, cushion 1532, or interface element. In any case, in at least some configurations, the headgear assembly 1500 can be used with various types of mask seals 1528, cushioning 1532 or other interface elements, including, for example, nasal cannulas, nasal pillows, nasal masks or full-face masks.

[0694] Figures 54-56 An interface assembly including a hood assembly 1500 is shown. This hood assembly may be identical or substantially identical to the hood assembly 1500 just described above, or may have another suitable arrangement. In the shown arrangement, the rear portion 1530 of the hood is collapsible. In some configurations, the rear portion 1530 of the hood can collapse or fold from an unfolded configuration in which the rear portion 1530 of the hood is in a three-dimensional form into a collapsed configuration in which the rear portion 1530 of the hood can be placed relatively flat. In the shown arrangement, a hinge, joint, or crease 1536 is provided among one or both of the rear strap and the top strap. The hinge, joint, or crease 1536 may include a section of the rear portion 1530 of the hood, which has a lower rigidity than the other parts of the rear portion 1530 of the hood. The hinge, joint, or crease 1536 may include a reduced portion of the rigid cap material, i.e., a separation between portions of the rigid cap material, such that one or more fabric layers define a connection between the hinge, joint, or crease 1536 or the separated portions of the rear portion 1530 of the cap, such as a stitched joint. Separate hinge members may be used to connect multiple portions of the rear portion of the cap.

[0695] This arrangement allows the hood to lie relatively flat, which helps in packing it while the user is walking with the mask on. The designed folds or creases allow the hood unit to maintain a shape that sustains its function, while also making it a compact unit even when already packed in a suitcase, etc. The folds or hinge lines 1536 can be constructed by any suitable process, such as by sewing or injection molding rigid material sections on both the left and right sides all the way to that point and then leaving one or more un-backed fabric pieces to act as hinges.

[0696] Figures 57-59 Another headgear assembly 1600 is shown, which, in at least some configurations, can be used with two or more interface types. For example, Figure 57 A headgear assembly 1600 is shown as a modular component forming an interface assembly including a full-face mask-type interface 1650. The headgear assembly 1600 may include a mating interface 1650 or a portion 1602 that can be otherwise coupled to the interface 1650. In some configurations, the mating or coupling portion 1602 of the headgear assembly 1600 may mat or couple to at least one other type of interface. For example, Figure 58 Showing the support for the nose mask 1660 Figure 57 The headgear assembly 1600 (shown in dashed lines), and Figure 59 Showcasing the 1670 support nose pillow / fork-head mask Figure 57 The headgear assembly 1600 (shown in dashed lines) is thus included. Therefore, in this modular arrangement, a single headgear assembly can be used with multiple types of interfaces. Advantageously, the on-demand resistance characteristics of the headgear assembly, as described herein, allow a single headgear assembly to operate suitably with different interface types. For example, the retention force provided by the headgear can be automatically adjusted to the force exerted on the headgear by the specific interface used. The engagement or connection portion 1602 can have any suitable arrangement, such as with a coupling... Figure 37-53 The disclosed arrangement methods are the same or similar.

[0697] The headgear assembly 1600 may generally be similar to other headgear assemblies disclosed herein or in the applicant's application number PCT / NZ2014 / 000074. Specifically, the illustrated headgear assembly 1600 includes a rear portion 1604, an interface connection portion 1602, and a length or circumference adjustment portion 1606 inserted between the rear portion 1604 and the interface connection portion 1602. The rear portion 1604 is configured to contact the rear of the user's head during use. The interface connection portion 1602 is configured to connect to an interface during use, such that the headgear assembly 1600 can support the interface in a suitable position on the user's face. The length or circumference adjustment portion 1606 is configured to allow adjustment of the position of the interface connection portion 1602 relative to the rear portion 1604 during use, such that the headgear assembly 1600 can be adjusted to fit a particular user's head size. Therefore, the length or circumference adjustment portion 1606 allows for adjustment of the circumference or perimeter of the cap so that the cap assembly 1600 can fit the head size of a particular user.

[0698] The rear portion 1604 of the hood can have any suitable arrangement, such as any of the same or similar arrangements described herein or in the applicant's application number PCT / NZ2014 / 000074. Preferably, the rear portion 1604 engages with the user's head and provides a relatively stable platform for connecting interfaces, such as using interface connection portion 1602 and circumference adjustment portion 1606. Thus, in at least some configurations, the rear portion 1604 is substantially inelastic, such that the rear portion of the hood maintains its shape and effective length in response to applied forces within the desired or anticipated range of application. The rear portion 1604 may include a top strap portion 1608 extending over the top of the user's head and a rear strap portion 1610 extending around the rear of the user's head. The top strap portion 1608 and the rear strap portion 1610 may be separate or connected in any suitable manner, such as by an intermediate connection portion 1612.

[0699] The length or circumference adjustment portion 1606 may have any suitable arrangement, such as any arrangement identical or similar to those described herein or in the applicant's application number PCT / NZ2014 / 000074. The circumference adjustment portion 1606 may include two pairs of adjustment elements 1614, wherein one pair of adjustment elements 1614 is positioned on each side of the hood assembly 1600. Therefore, the illustrated hood assembly 1600 can generally be described or classified as a two-fixed-plane hood type. The hood assembly 1600 can be described as a hood type with two fixed planes converging forward, or possibly a mixture of a hood type with two fixed planes converging forward and a hood type with two fixed planes separated / angled.

[0700] Each pair of adjustment elements 1614 can be connected to one side of the back portion 1604 of the hood and one side of the interface connection portion 1602. The pair of adjustment elements 1614 on each side are connected to the back portion 1604 at spaced intervals. For example, one of the adjustment elements 1614 is connected to the back portion 1604 at or near a portion of the top strap 1608, and the other of the adjustment elements 1614 is connected to the back portion 1604 at or near a portion of the back strap 1610. In the illustrated arrangement, the upper adjustment element 1614 is connected to a forward extension of the back portion 1604 that extends forward from the top strap 1608 at or near the user's ears. The lower adjustment element 1614 is connected to the end of the back strap 1610 of the back portion 1604.

[0701] Adjustment element 1614 is adjustable in length between a retracted length and an extended length. In some configurations, adjustment element 1614 cooperates to provide full or substantially full adjustment of the circumference of the hood assembly 1600. Each of adjustment elements 1614 may also include a resilient element or biasing device that biases the adjustment element 1614 toward one of the retracted or extended lengths. Preferably, adjustment element 1614 is biased toward the retracted length, such that hood assembly 1600 is biased toward its minimum circumference. This arrangement allows hood assembly 1600 to be extended and then automatically retracted under the biasing force of the resilient element or other biasing device of adjustment element 1614 to fit a particular user. Additionally, preferably, adjustment element 1614 defines a hard stop or maximum extended length to limit the extension of hood 1600 and define the maximum circumference of hood 1600.

[0702] In some configurations, each of the adjusting elements 1614 includes a knitting element that can be extended or retracted in length. The knitting element may include one or more elastic elements parallel to the knitting element. These elastic elements may be separate from or included within the knitting element. In some configurations, these elastic elements are housed within the internal space between the filaments of the knitting element. Examples of suitable knitting elements are associated with the applicant's patent application number PCT / NZ2014 / 000074. Figures 46-54 As described above. However, other suitable constructions or arrangements may also be used. Alternatively, the elastic element or biasing element may be located within the interface connection portion and may interact with the core member to pull the core member into the interface connection portion.

[0703] The interface connection portion 1602 of the headgear assembly 1600 may extend between a pair of adjustment elements 1614 constituting the circumference adjustment portion 1606. In some configurations, the interface connection portion 1602 may be relatively rigid. In some configurations, the interface connection portion 1602 is directly coupled to the adjustment element 1614. As described above, the interface connection portion 1602 may facilitate the connection of the headgear assembly 1600 to the interface. However, the interface connection portion 1602 may also accommodate at least a portion of one or more directional locks 1616. In the illustrated arrangement, two pairs of directional locks 1616 are provided, with one directional lock 1616 associated with each of the adjustment elements 1614. A portion of the directional lock 1616 (e.g., housing 1618) may be located at each end of the interface connection portion 1602. In some configurations, the core member 1620 associated with each of the directional locks 1616 is coupled to the rear portion 1604 of the cap, extends along or through the adjustment element 1614, through the housing 1618 of the directional lock 1616, and into the collection space 1622. The collection space 1622 may be defined by a collection tube or conduit, which may be a separate component from or incorporated into the interface connection portion 1602. The housing 1620 of the directional lock 1616 may include one or more members or elements (e.g., locking washers or locking claws) that interact with the core member 1618 to selectively allow the cap assembly 1600 to retract or lock the cap assembly 1600 within a specific circumference, and to inhibit or prevent cap elongation at least under forces below the yield force provided by the directional lock. Further operational details of the directional lock 1616 are described above and in the applicant's patent application number PCT / NZ2014 / 000074.

[0704] In the illustrated arrangement, the directional locks 1616 on each side of the interface connection portion 1602 are vertically stacked or positioned side-by-side. Although the directional locks 1616 are shown as separate units, in some configurations, the multiple parts of the directional locks 1616 can be integrated. For example, a single housing can accommodate individual locking elements that interact with the separate core components of each adjusting element.

[0705] The interface connection portion 1602 may be curved, and the collection space 1622 (e.g., defined by a collection tube or channel) may be curved along with the interface connection portion 1602. In the illustrated arrangement, the central portion of the interface connection portion 1602 is located above the end portions of the interface connection portion 1602. Furthermore, when viewed from the front, the side portions of the interface connection portion 1602 curve downward from the central portion. Therefore, the interface connection portion 1602 may be complementary to or correspond to the shape of the body or shell portion of the full-face mask interface 1650. The central portion of the interface connection portion 1602 may be located above the bend or other conduit connector of the mask 1650. Similarly, the interface connection portion 1602 may be configured to be complementary to or correspond to the shape of the body or shell portion of the nasal mask interface 1660. The central portion of the interface connection portion 1602 may be located above the bend or other conduit connector of the nasal mask 1660. The interface connection portion 1602 can be configured to complement or correspond to the shape of the body or shell portion of the nasal pillow / fork head mask 1670. The central portion of the interface connection portion 1602 can be located above the bend or other conduit connector of the nasal pillow / fork head mask 1670. In some configurations, the interface connection portion 1602 can be located between the bend or other conduit connector and the pillow / fork head of the nasal pillow / fork head mask 1670.

[0706] Figure 60 It demonstrates its compatibility with other interface components disclosed herein in many ways (such as...) Figure 37-53 and Figures 57-59 The interface component is similar to the interface component 1680. Figure 60 The interface assembly 1680 includes a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nose shield. The headgear assembly 1600 generally includes a rear portion 1604 of the headgear, a length or circumference adjustment portion 1606, and an interface connection portion 1602. Figure 60 The headgear 1600 is relative to Figure 37-53 and Figures 57-59 These interface assemblies are described in the context of their differences. Features or details not described may be related to... Figure 37-53 Interface components, Figures 57-59 The interface components are identical or similar in characteristics or details to other interface components disclosed herein or in the applicant’s application number PCT / NZ2014 / 000074, or may have any other suitable arrangement.

[0707] Figure 60The hood assembly 1600 can be described or classified as a hood type with two parallel fixation planes. The illustrated rear portion 1604 of the hood includes a top strap 1608, a pair of upper straps 1624, and a pair of lower straps 1626. The rear portion 1604 includes a vertically elongated middle rear portion 1628 extending between and connecting the upper straps 1624 and the lower straps 1626. The illustrated interface connection portion 1602 is in the form of a support frame 1630 for a shell portion 1682 used for a full-face mask or nose mask. The shell portion 1682 and the bend 1684 or other conduit connector (collectively referred to as the "bend") can be directly or indirectly secured to the frame 1630 by any suitable means. For example, the casing portion 1682 and the bend 1684 can be separately connected to the support frame 1630 (directly or indirectly). The casing portion 1682 can be directly connected to the frame 1630 and the bend 1684 can be connected to the casing portion 1682, or the bend 1684 can be directly connected to the frame 1630 and the casing portion 1682 can be connected to the bend 1684.

[0708] In the illustrated arrangement, the interface connection portion or support frame defines a forehead brace or T-shaped member 1632. A pair of upper adjustment elements 1614, including a circumference adjustment portion 1606, can be attached to the T-shaped member 1632, such that the upper adjustment elements 1614 are positioned above the user's eyes and extend above the user's ears. A pair of lower adjustment elements 1614, including a circumference adjustment portion 1606, can be attached to the lower portion of the support frame 1630 (directly or via another component, such as a housing), such that the lower adjustment elements 1614 are positioned below the user's eyes and ears. A collection space 1622 for the upper adjustment elements 1614 (e.g., defined by a collection tube or channel) can bend downwards along the T-shaped member 1632 toward a bend and extend therein. An upper directional lock 1616 can be carried by the T-shaped member 1632. A lower directional lock 1616 can be carried by the lower portion of the support frame 1630 (directly or indirectly).

[0709] Figure 60The fine-tuning capability offered by the headgear assembly or interface assembly 1680 is particularly advantageous in the T-piece configuration because it allows for quick and easy minor adjustments to the fit around the user's nose bridge (which can be a particularly sensitive area). Although each connection between the rear portion 1604 of the headgear and the interface connection portion 1602 or interface is shown as an automatic adjustment device, in some configurations, a combination of automatic and manual adjustment devices may be used. For example, the upper connection (e.g., the connection to the T-piece 1632) may be manually adjustable (such as a hook-and-loop fastener), and the lower connection may be automatically adjustable. In this arrangement, the upper connection can be set and maintained in place during multiple fit cycles, while the lower connection provides the full elongation required to put on and take off (“remove”) the headgear assembly or interface assembly 1600. This arrangement may, for example, provide some of the advantages of automatic adjustment at a lower price point. Other suitable combinations may also be used, such as manual adjustment on the lower side and automatic adjustment on the upper side, or manual adjustment on one side and automatic adjustment on the opposite side.

[0710] Figure 61 It demonstrates its compatibility with other interface components disclosed herein in many ways (such as...) Figure 37-53 , Figures 57-59 and Figure 60 The interface component is similar to the interface component 1680. Figure 61 The headgear 1600 is relative to Figure 37-53 , Figures 57-59 and Figure 60 These interface assemblies are described in the context of their differences. Features or details not described may be related to... Figure 37-53 Interface components, Figures 57-59 Interface components, Figure 60 The interface components are identical or similar in characteristics or details to other interface components disclosed herein or in the applicant’s application number PCT / NZ2014 / 000074, or may have any other suitable arrangement.

[0711] Figure 61 The interface assembly 1680 includes a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nose shield. The headgear assembly generally includes a rear portion 1604, a length or circumference adjustment portion 1606, and an interface connection portion 1602. However, unlike... Figure 60 Interface components, Figure 61 The interface component 1680 does not include a forehead brace or T-shaped piece 1632. Therefore, each of the pair of upper adjustment elements 1614 is relative to... Figure 60 The interface component 1680 is connected to the interface connection portion 1602 or the interface at a lower position. For example, the upper adjustment element 1614 may generally follow the cheek and pass below the user's eyes.

[0712] Figure 61 The hood assembly 1600 can be described or classified as a hood type with two separate / angled retaining planes. Upper and lower adjustment elements 1614 are spaced apart on the face mask 1650 to provide a retaining force to the face mask 1650 in a spaced vertical position, which provides stability to the face mask 1650. The hood assembly 1600 can be attached to the face mask 1650 by separate interface connection portions 1602, each of which can be substantially similar to a combined... Figures 57-60 The described interface connection portion 1602. One of the interface connection portions 1602 may be located on the lower portion (e.g., lower half) of the face mask 1650, and the other of the interface connection portions 1602 may be located on the upper portion (e.g., upper half) of the face mask 1650. The lower interface connection 1602 may be via a bend or other conduit connector. In some configurations, the upper and lower interface connection portions 1602 may be coupled to or integrated with each other. For example, a bridge portion may extend between and connect the upper and lower interface connection portions 1602. The bridge portion may be separate from or integral with one or both of these interface connection portions.

[0713] Figure 62 It demonstrates its compatibility with other interface components disclosed herein in many ways (such as...) Figure 37-53 , Figures 57-59 , Figure 60 and Figure 61 The interface component is similar to the interface component 1680. Figure 62 The headgear 1600 is relative to Figure 37-53 , Figures 57-59 , Figure 60 and Figure 61 These interface assemblies are described in the context of their differences. Features or details not described may be related to... Figure 37-53 Interface components, Figures 57-59 Interface components, Figure 60 Interface components, Figure 61 The interface components are identical or similar in characteristics or details to other interface components disclosed herein or in the applicant’s application number PCT / NZ2014 / 000074, or may have any other suitable arrangement.

[0714] Figure 62 The interface assembly 1680 includes a headgear assembly 1600 and an interface in the form of, for example, a full-face mask 1650 or a nose shield. The headgear assembly 1600 generally includes a rear portion 1604, a length or circumference adjustment portion 1606, and an interface connection portion 1602. However, unlike... Figure 60 and 61 The interface component 1680, for example, Figure 62The interface connection portion 1602 of the interface assembly 1680 does not extend between the adjustment elements located on opposite sides of the interface assembly 1680 or the headgear assembly 1600. Instead, the interface connection portion 1602 connects to the adjustment elements 1614 located on the same side of the interface assembly 1680 or the headgear assembly 1600. That is, each of the pair of interface connection portions 1602 connects the upper and lower adjustment elements 1614 on one side of the interface assembly 1680 or the headgear assembly 1600 to each other.

[0715] In the illustrated arrangement, the interface connection portion 1602 is a generally U-shaped component having an upper end portion 1634 connected to the upper adjusting element 1614 and a lower end portion 1636 connected to the lower adjusting element 1614. A curved portion of the interface connection portion 1602 extends between the upper end portion 1634 and the lower end portion 1636. Orientation locks 1616 for the upper and lower adjusting elements 1614 can be carried by the corresponding upper end portion 1634 and lower end portion 1636. Collection spaces 1622 (e.g., defined by collection pipes or channels) can be curved along the central curved body portion of the interface connection portion 1602 and, in some configurations, can overlap each other.

[0716] exist Figure 62 In this arrangement, the headgear assembly 1600 itself may not define the entire closed perimeter. Instead, the interface 1650 may form part of the closed perimeter, and thus, part of the circumference or peripheral length of the interface assembly 1680. Advantageously, this arrangement allows the interface assembly 1680 to be optionally configured to have a closed perimeter that can be quickly and easily opened for putting on or taking off the interface assembly 1680. That is, one (or both) of the interface connecting portions 1602 may be removably attached to the interface 1650 (e.g., by one or more clips), such that one (or both) of the interface connecting portions 1602 can be disconnected and the closed perimeter can be opened. In some configurations, an automatic adjustment mechanism may be provided only on one side of the interface assembly. Similarly, other interface assemblies or headgear assemblies disclosed herein or in the applicant's application number PCT / NZ2014 / 000074 may have a unilateral or asymmetrical arrangement, wherein an automatic adjustment mechanism may be provided only on one side.

[0717] Figures 63-65 Showing the wearing Figure 62 A series of discrete positions or steps of the interface component 1680. Figure 63 The illustration shows a user positioning the interface so that the interface connector 1602 is attached to one side of the head, the interface assembly 1600 is wrapped around the back of the head, and the disconnected interface connector 1602 is pulled towards the face. Figure 64In the middle, the interface is brought toward the appropriate position on the face, and the disconnected interface connection part 1602 is brought toward the interface 1680. Figure 65 The interface 1680 is shown in the appropriate position on the user's face, and the user reconnects or disconnects the interface connection portion 1602 to close the peripheral loop. Figure 64 and 65 Partial or complete movement between them may require the yielding force of the directional lock, as described above. To remove or detach interface component 1680, the procedure can be reversed.

[0718] Figure 66 and 67 Correspondingly, the automatically adjustable perimeter of the interface component or headgear component 1700 in a first position (e.g., minimum perimeter length) and a second position (e.g., maximum perimeter length) is shown. As described with respect to the interface component and headgear component disclosed herein, the perimeter may include a length L defined by the rear portion 1704 of the headgear. 后部 In some configurations, the length L 后部 It can be zero. In other words, the fixed-length rear section 1704 of the cap can be omitted, and the rear section can be formed by a length-adjustable part or an elastic component. In addition, one or more of these surrounding sections can be located in alternative positions or can be divided into multiple sections.

[0719] The perimeter may also include the length L defined by the perimeter or length adjustment portion 1706. 弹性 In the illustrated arrangement, the length is defined by a pair of elastic or adjustable elements 1714. However, in other configurations, among other suitable arrangements, the perimeter or length adjustment portion 1706 may be defined by one or more elastic or adjustable elements 1714. As described above, in some configurations, the defined length L... 后部 The rear portion 1704 of the cap can be omitted, and the length adjustment portion 1706 can extend along the entire perimeter from one end of the interface connection portion 1702 to the other end of the interface connection portion 1702. Figure 66 and 67 In the middle, L 弹性 The length is correspondingly represented by the minimum length L. 最小 and maximum length L 最大 The relative position indicator is used for marking.

[0720] The surrounding area may also include the collector length L. 收集器This can represent the individual or total available length of the collection space 1722 for receiving excess portions of the core element of the directional locking device. As described above, the collector space 1722 does not necessarily extend from one adjustable element 1714 to another and thus define a physical segment of its peripheral length. For example, in Figure 62 In the interface component 1680, the collector space 1622 does not extend between the opposing adjustable elements 1614. Therefore, physically, the interface connection portion 1602, the interface 1650, or other structures can define a portion of the peripheral length. However, conceptually, the flexible length L... 弹性 (Minimum length L) 最小 and maximum length L 最大 )limited Figure 66 and 67 The length of the surrounding area is adjustable, while the remaining part (the length L of the back part of the cap) is adjustable. 后部 and collector length L 收集器 It has a fixed length.

[0721] In the arrangement shown, the perimeter length can include the length L of the back portion of the headgear. 后部 Collector length L 收集器 and total elastic length L 弹性 The sum, or defined by them, in the configuration shown, because two equivalent length-adjustable elements 1714 are provided, the total elastic length is twice (2x)L. 弹性 The total elastic length L at any point in time or at any specific location of the interface or headgear assembly 1700. 弹性 Equal to minimum length L 最小 Or maximum length L 最大 Or some value somewhere in between. As described herein, each core component L 芯部 The length is preferably greater than or equal to the maximum length L of each adjustable element. 最大 And therefore, the total core component length L 芯部 Preferably greater than or equal to the total maximum length L 最大 This allows the cap assembly to unfold to its maximum peripheral length without fully pulling the core member through the directional locking element. In other words, preferably, when the cap assembly is unfolded to its maximum peripheral length, a portion of the core member is available for engagement by the directional locking element.

[0722] Additionally, preferably, the collector length L 收集器 Sufficient to accommodate the total excess or unused portion of the core component at the minimum and maximum perimeter lengths of the headgear assembly. Therefore, in at least some configurations, the individual or total core length L... 芯部 Less than or equal to the maximum length L, either individually or in total 最大Add individual or total collector length L 收集器 In at least some configurations, the individual or total core length L 芯部 Less than or equal to the minimum length L, either individually or in total 最小 Add individual or total collector length L 收集器 In some configurations, the individual or total maximum length L 最大 Less than or equal to the individual or total core length L 芯部 Individual or total core length L 芯部 Less than the individual or total maximum length L 最大 Add individual or total collector length L 收集器 The length of the directional locking mechanism is not specifically shown in the perimeter, but it can be considered to form the rear portion L of the cap. 后部 Elastic length L 弹性 Or collector length L 收集器 A portion of the length of any one of them. In any case, the core L can be determined. 芯部 The minimum length is determined by taking the length of the directional locking mechanism into account.

[0723] In at least some configurations, the individual or total core length L 芯部 It can be greater than the individual or total elastic length L 弹性 With collector length L 收集器 The sum. In at least some configurations, the individual or total core length L 芯部 It can be either individually or in total maximum length L 最大 Length L of the back part of the cap 后部 Between, or can be equal to the single or total maximum length L 最大 and the length L of the back part of the hat 后部 Any one of them.

[0724] Figure 66 and 67 The surrounding area can represent the actual surrounding area of ​​the interface component or the header component. That is to say, Figure 66 and 67 The periphery can represent the physical construction of a single-fixed-plane interface or a headgear assembly, or the physical construction of one of the fixed-plane interfaces or a headgear assembly. However, as described, Figure 66 and 67 The perimeter can conceptually represent other interface or headgear types. The perimeter shown can represent a single retention plane (e.g., upper or lower) of a multi-retention-plane headgear type or can represent, for example, but not limited to, the average of two or more retention planes of a multi-retention-plane headgear type.

[0725] Figures 68A to 68DAn embodiment of an directional lock is shown, comprising a housing 1810, a first locking element and a second locking element (e.g., washers 1820, 1822), and a core member 1830. The housing includes a first channel 1840 and a second channel 1842, wherein the first channel 1840 and the second channel 1842 are configured to correspondingly receive the first locking washer 1820 and the second locking washer 1822. In the illustrated arrangement, the first channel 1840 and the second channel 1842 are separated by an inner wall 1812 of the housing 1810. However, in other arrangements, the first channel 1840 and the second channel 1842 need not be physically separated spaces, but can be multiple portions of a single channel. The housing 1810 has two end walls 1814, which, together with the inner wall 1812, have an elongated core opening 1860 through which the core member 1830 passes. The core openings 1860 are substantially aligned with each other. The core opening 1860 of the end wall 1814 shown on the right side of the figure is larger than that of the inner wall 1812 and the core opening of the end wall 1814 shown on the left side of the figure. This allows the maneuvering core member 1830 to pass through the housing 1810. The first channel 1840 and the second channel 1842 are each defined by one of the inner wall 1812, the end wall 1814, and a pair of side walls 1816; wherein the side walls 1816 extend between the end walls 1814 of the housing 1810. The first channel 1840 and the second channel 1842 are configured to be open at one or both of the top and bottom of the housing 1810.

[0726] Each of the first channel 1840 and the second channel 1842 has a pair of washer retainers 1850 aligned on opposite sidewalls 1816 of the housing 1810. Each pair of washer retainers 1850 is configured to pivotally retain a first locking washer 1820 or a second locking washer 1822 within the corresponding first channel 1840 or second channel 1842. The washer retainer includes a circular bushing 1852 and an elongated slot 1854, wherein the circular bushing 1852 intersects the bottom of the housing, thus forming an inlet. The inlet is configured to allow the first locking washer 1820 and / or the second locking washer 1822 to be received into the washer retainer 1850. The slot 1854 extends radially from the circular bushing 1852 toward the top of the housing 1810.

[0727] The first washer 1820 and the second washer 1822 each include a cylindrical shaft 1824 and an arm extending from the shaft 1824. The cylindrical shaft 1824 has substantially the same width W as the housing 1810, and the arm is narrower to fit within the first channel 1840 and the second channel 1842. In the illustrated arrangement, the arm includes a first segment 1872 and a second segment 1874, wherein the first segment 1872 extends radially or vertically from the cylindrical shaft 1824, and the second segment 1874 extends at an obtuse angle to the end of the first segment 1872. The first segment 1872 of the arm of the first washer 1820 is shorter than the first segment 1872 of the arm of the second washer 1822. The angle between the first segment 1872 and the second segment 1874 of the arm of the first washer 1820 is greater than the corresponding angle of the second washer 1822. These angles can be selected such that the second section 1874 of one or both of the first washer 1820 and the second washer 1822 rests substantially flat against the corresponding wall (e.g., correspondingly, the inner wall 1812 and the end wall 1814) of the housing 1810 at one of the positions of the washer 1820 and 1822. The second section 1874 of the arm includes a centrally located circular aperture 1876 configured to receive the core member 1830. The first channel 1840 and the second channel 1842 differ in size according to the size of the washer to be housed therein, i.e., the first channel 1840 is smaller than the second channel 1842 because the first washer 1820 is smaller than the second washer 1822.

[0728] The cylindrical shaft 1824 of the first locking washer 1820 and the second locking washer 1822 has a diameter substantially the same as the diameter of the circular bushing 1852 of the washer retainer 1850, and is configured to be received and held by the circular bushing 1852 in a snap-fit ​​configuration. This snap-fit ​​configuration is provided because the inlet of the circular bushing 1852 is narrower than the diameter of the cylindrical shaft 1824. The slot 1854 of the washer retainer 1850 is configured to allow the inlet to flex open, thereby increasing the ease with which the first locking washer 1820 and the second locking washer 1822 can be pushed through these inlets and assembled into the housing 1810. Once assembled within the first channel 1840 and the second channel 1842 of the housing 1810, the first washer 1820 and the second washer 1822 can be retracted and pivoted around a central axis extending through the cylindrical shaft 1824.

[0729] The core member 1830 is configured to pass through a core opening 1860 in the housing 1810 and an aperture 1876 for the first washer 1820 and the second washer 1822. Applying tension to the core member 1830 causes the first locking washer 1820 and the second locking washer 1822 to pivot back and / or toward a locked position and / or an open position. Figure 68A and 68BA directional lock in a locking configuration is shown, in which a force is applied to the core member 1830 in a direction toward the left of the drawing (as indicated by the arrow). In this configuration, the force applied to the core member 1830 causes the first locking washer 1820 and the second locking washer 1822 to pivot in a counterclockwise direction, such that the path of the core member 1830 through the directional lock 1800 is non-linear or tortuous and the movement of the core member 1830 is restricted. Figure 68C and 68D A directional lock in an open configuration is shown, in which force is applied to the core member 1830 in a direction toward the left of the drawing (as indicated by the arrow). In this configuration, the first locking washer 1820 and the second locking washer 1822 are pivoted clockwise, such that the circular orifice 1876 and the core opening 1860 are aligned substantially in a straight line. This provides a smooth path for the core member 1830 to be pulled substantially freely through the directional lock 1800. Further operational details of the directional lock 1800 are described above and in the applicant's patent application number PCT / NZ2014 / 000074.

[0730] Figures 69A-69B A non-limiting exemplary embodiment of the housing 1810 and the first locking washer 1820 and the second locking washer 1822 is shown. The first locking washer 1820 and the second locking washer 1822 are configured to be molded as a single component, wherein they are connected by a runner and gating system 1900 known in the prior art. The runner and gating system is configured to serve as an assembly assisting the first locking washer 1820 and the second locking washer 1822, wherein the runner and gating system 1900 can be gripped by a person or machine to align the first washer 1820 and the second washer 1822 with the washer retainer 1850 of the housing 1810. Forces (as indicated by arrows) can be applied to the locking washers 1820, 1822 through the gating and runner system 1900 to provide relative movement between the housing 1810 and the locking washers 1820, 1822. This relative movement can be used to engage the first locking washer 1820 and the second locking washer 1822 with the housing 1810, such that the cylindrical shaft 1824 of the locking washers 1820 and 1822 is snapped into the circular bushing 1852 of the washer retainer 1850.

[0731] like Figure 69B As shown, once the first locking washer 1820 and the second locking washer 1822 are assembled within the housing 1810, the gate and runner system 1900 can be disconnected from or detached from the locking washers 1820, 1822. This can be done in the direction in which the assembly force is applied ( Figure 69AA force is applied to the gate and runner system 1900 in a substantially vertical direction (as indicated by the arrow) to disengage the gate and runner system 1900 from the locking washers 1820, 1822. When the gate and runner system 1900 disengages, the locking washers 1820, 1822 remain assembled with the housing 1810. The gates 1910 of the gate and runner system 1900 can be designed with a weakness that causes these gates to break as close as possible to the cylindrical shaft 1824 of the locking washers 1820, 1822, thus ensuring that the range of pivoting movement of the locking washers 1820, 1822 is not limited by excess gate material.

[0732] Figure 70A and 70B An embodiment is shown in which multiple sets of first locking washers 1820 and second locking washers 1822 are molded together on a single gate and runner system 1900. This configuration allows for the immediate or sequential assembly of multiple locking washers 1820, 1822, thereby improving manufacturing efficiency. To assemble multiple sets of locking washers 1820, 1822 into the housing 1810, the runner and gate system 1900 can be gripped by a person or machine to align the first washers 1820 and second washers 1822 with the washer retainers 1850 of each of the housings 1810. Force can be applied through the gate and runner system 1900 (as indicated by the arrow) to engage multiple sets of first locking washers 1820 and second locking washers 1822 with the housing 1810, such that the cylindrical shaft 1824 of the locking washers 1820, 1822 is snapped into the circular bushing 1852 of the washer retainer 1850.

[0733] Figure 71 A non-limiting exemplary configuration of a housing 1810 for assembling a first locking washer 1820 and a second locking washer 1822 to a directional lock 1800 is shown. This configuration includes a gripping portion or element, such as a gripping tab 1830, for aligning to and applying an assembly force to the locking washers 1820, 1822. The gripping tab 1830 is formed between the locking washers 1820, 1822 and the gate and runner system 1900, and may have a geometry specifically configured to be easily gripped by a person or machine. In some configurations, the gate and runner system 1900 is configured to be removed from the gripping tab 1830 during molding. In a variation of this configuration (not shown), multiple pairs of first locking washers 1820 and second locking washers 1822 may be connected by a single gripping tab 1830, which is then used to assemble the directional lock in a single action.

[0734] Figure 72A non-limiting exemplary embodiment of the directional lock is shown. In this embodiment, washer retainers 1850 are positioned in an opposing arrangement, wherein a first washer retainer 1850 extends downward from the top of the housing and a second washer retainer 1850 extends upward from the bottom of the housing. A first locking washer 1820 and a second locking washer 1822 are assembled to the housing 1810 in opposite directions. For example, a lock can be used as described above. Figures 69A to 71 The embodiments described use gripping tabs 1830 or gate and runner system 1900 to assist in assembling locking washers 1820, 1822 to housing 1810.

[0735] Figure 73-80 An interface with a headgear device is shown, configured to allow the interface to be put on and taken off like a baseball cap. Preferably, the headgear device does not include a strap passing below the user's ears. Therefore, an interface with such a headgear device can be put on or put on by passing the interface over the user's head from above. The headgear device can be positioned on the back of the user's head, and then the interface device can be rotated downwards and positioned on the user's face, or vice versa. These headgear devices may include a portion located in front of the user's ears, which can provide a mounting position for orienting to or indirectly connecting to the interface. In some configurations, the rear portion of the headgear device is relatively rigid (e.g., to maintain an open shape when not on the user) and / or relatively non-extendable.

[0736] Figure 73 An alternative device to a hood system 2000 configured for use with a full-face mask 2100 having a forehead support is shown. However, the hood system 2000 or portions thereof can also be used with other types of interfaces, including interfaces with forehead supports, if desired. The full-face mask 2100 is configured to seal around the user's nose and mouth, wherein the full-face mask contacts the bridge of the nose, cheeks, and lower lip or chin area. The hood system 2000 includes a rear portion 2010, an upper retention plane 2020, and a lower retention plane 2030.

[0737] Preferably, the back portion 2010 of the hood engages with the user's head and provides a relatively stable platform for connecting interfaces, such as the interface connection portion 2040 and the circumference adjustment portion (e.g., the orientation locking module 2060). Therefore, in at least some configurations, the back portion 2010 is substantially inelastic, such that the back portion maintains its shape and effective length in response to applied forces within a desired or anticipated range. In some configurations, the back portion 2010 may include a layer of relatively rigid material (such as a plastic material) bonded to one or more fabric material layers. Preferably, the fabric layer is provided at least on the surface of the rigid material layer that contacts the user. In some configurations, the fabric layer is provided on each side of the rigid material layer. Furthermore, in some configurations, the rigid material layer may be formed between these material layers, such as by injection molding the rigid material into a space within a model located between two material layers. Examples of such a headgear and methods of manufacturing such a headgear are disclosed herein by reference in U.S. Provisional Application No. WO 62 / 050,925.

[0738] The rear portion 2010 of the hood includes arms 2012 extending in front of the user's ears. Arms 2012 include connectors 2014 configured to provide a series of vertically spaced positions at which one or more directional locking modules 2060 can be attached. The full-face mask is generally larger and heavier than the direct nose mask of the previous embodiment. Therefore, a full-face mask may require more than one retaining plane to provide the desired or required level of stability in order to achieve a substantially airtight seal with the user's face.

[0739] Two retention planes 2020 and 2030 converge toward a single point located on each side of the full-face mask 2100 or possibly in front of the full-face mask, wherein they may or may not intersect. The retention planes 2020 and 2030 may be vertically spaced apart from each other, such that they are further spaced apart at their points of connection with the hood than at their points of connection with the mask. This provides a degree of stability to the interface. For example, the upper retention plane 2020 may pass over the top of the ear, the user's nose, or above the nose, and the lower retention plane 2030 may reach from the bottom of the ear to near or below the user's mouth.

[0740] Each of the two retention planes 2020, 2030 can be provided by two directional locking modules 2060, one of which is located on each side of the hood system 2000. Each directional locking module 2060 includes a directional lock 2062 and an elastic portion 2064, which is connected at one end to the directional lock 2062 and at the other end to a plurality of connectors 2014. The angles of the retention planes 2020, 2030 can be adjusted by connecting the elastic portion 2064 to the different connectors 2014 on the hood arm 2012. The full-face mask 2100 shown does not include a forehead brace or a "T-shaped element." However, a T-shaped element may be provided in some configurations. Additional hood elements or straps can be used to attach the rear portion of the hood to the T-shaped element of the mask, if desired.

[0741] Figure 74 A headgear system assembly 2000 is shown, comprising a rear portion 2010 of the headgear and two retaining surfaces 2020, 2030 configured to secure a full-face mask 2100 to a user's face. In this arrangement, the full-face mask 2100 is configured to seal below the user's nose and around their mouth, thus preventing the mask 2100 from contacting the bridge of the nose. Compared to previous embodiments, the different sealing positions require different angles for the retaining surfaces 2020, 2030 to apply force to the mask in an optimal or desired direction, or at least to make it desirable. Figure 74 In the diagram, two retaining planes 2020 and 2030 are shown as vertically spaced and attached to the arm 2012 of the rear portion 2010 of the cap, resulting in an upper retaining plane 2020 and a lower retaining plane 2030 that are substantially parallel to each other. Compared to the upper retaining plane 2020 of the previous embodiment, the upper retaining plane 2020 is more horizontal and located lower on the user's face. The angles of the retaining planes 2020 and 2030 can be achieved via multiple connectors 2014, such as... Figure 73 Those adjustable as shown in the embodiments.

[0742] Each of the retaining planes 2020 and 2030 is shown to include a directional locking module 2060, which further includes an elastic portion 2064 and a directional lock 2062. In a variation of this arrangement, each directional locking module 2060 may include more than one directional lock 2062.

[0743] Figure 75 The diagram shows the combination with the nose mask 2110. Figure 73The headgear system 2000. The nose shield 2110 is configured to seal around the user's nose, contacting the bridge of the nose, cheeks, and upper lip. It is desirable or possible to require two retention planes 2020, 2030 to provide appropriate stability to the face shield 2110 when worn on the user's face.

[0744] Figure 76 A non-limiting exemplary embodiment of a headgear system 2000 is shown, including a rear portion 2010 of the headgear and two retention planes 2020 and 2030 configured to secure a nose shield 2110 to a user's face. The rear portion 2010 includes a molded plastic structure 2016 with an integrally formed fabric cover and arms extending downward in front of the user's ears. The upper retention plane 2020 and the lower retention plane 2030 are provided by directional locking modules 2060 on each side of the headgear. The upper retention plane 2020 extends from the top of the arm 2012 to a position just above the tip of the user's nose. The lower retention plane 2030 extends from the bottom of the arm 2012 to a position approximately below the user's nose. In the illustrated arrangement, the directional locking module 2060 includes a braided elastic portion, a core filament (not shown), and a directional lock, wherein the braided elastic portion and the core filament are permanently connected to the headgear arm 2012 and the directional lock 2060 by a covered molded connector. The angles of the retaining planes 2020 and 2030 are fixed by the covered molded connector 2016.

[0745] Figures 77 to 79 A view of a headgear system 2200 according to the subject matter currently disclosed is shown. The headgear system 2200 is a closed loop and includes a headgear 2210, two upper-positioning locking modules 2220, two lower-positioning locking modules 2230, and a housing 2240. The rear portion 2250 of the headgear includes a forked molded plastic structure with an integrally formed fabric cover, and a pair of arms 2252 configured to extend downward in front of the user's ears during use.

[0746] The upper directional locking module 2220 and the lower directional locking module 2230 include an elastic portion 2222, a core filament (not shown), and a directional lock 2224. The core filament is configured to extend partially or completely along the length of the elastic portion 2222 and through the directional lock 2224. The directional lock 2224 is configured to interact with the core filament to allow automatic adjustment of the lengths of the directional locking modules 2220 and 2230. The core filament and the elastic portion 2222 are permanently connected to the arm 2252 of the cap 2210 by an overmolded connector 2260, wherein the upper directional locking module 2220 is connected to the upper region of the arm 2252 and the lower directional locking module 2230 is connected to the lower region of the arm 2252. The elastic portion 2222 is permanently connected to the directional locks 2220 and 2230 by the overmolded connector 2260. The directional locks 2220 and 2230 are housed within the housing 2240. Two upper directional locking modules 2220 form an upper retaining plane, and two lower directional locking modules 2230 form a lower retaining plane. These retaining planes are aligned with... Figure 76 Those are basically the same.

[0747] The housing 2240 includes a substantially rigid body having four directional locking brackets 2242, an upper conduit 2244, a lower conduit 2246, and a central opening 2248 formed between the upper and lower conduits. Two directional locking brackets 2242 are positioned vertically relative to each other at each of the lateral ends of the housing 2240. The directional locking brackets 2242 are configured to retain directional locks 2224. The upper conduit 2244 extends laterally between the two upper locking brackets 2242, and the lower conduit 2246 extends laterally between the lower locking brackets 2242. The upper conduit 2244 and the lower conduit 2246 are configured to receive the free ends of the core filament. The central opening 2248 formed between the upper conduit 2244 and the lower conduit 2246 is configured to receive a nasal mask device.

[0748] Figure 80 It shows Figure 79The headgear system, together with a nose mask device 2270 configured to be assembled with the headgear system, includes a frame assembly 2280 and a cushioning module 2290. The frame assembly 2280 includes a frame 2282, a bend 2284, and a tube connector 2286. The frame 2282 and the bend 2284 are configured to be connected together by a ball-and-socket connector, wherein the frame 2282 includes a socket 2410 and the bend 2284 includes a ball 2400. The frame 2282 includes a nylon component having a geometry that provides a repeatably removable snap-fit ​​connection with the housing 2240 of the headgear system 2200. In some configurations, the bend is made of a different material than the frame 2282, such as polycarbonate, so that the two parts are not glued together during assembly. This increases the degree of freedom of movement of the bend relative to the frame 2282 and reduces hose drag. It is contemplated that other material combinations may also be used.

[0749] Tube connector 2286 is attached to the end of bend 2284 in a snap-fit ​​configuration, opposite to the end attached to frame 2282. Tube connector 2286 is rotatable or swivelable about the end of bend 2284. In some embodiments, tube connector 2286 may be made of a different material than bend 2284, such as nylon. Tube connector 2286 is configured to provide means for connecting nasal mask device 2270 to a CPAP tube providing a pressurized air supply.

[0750] The cushioning module 2290 includes a sealing cushion 2292 integrally formed with the connector portion 2294 by means such as, but not limited to, overmolding. The sealing cushion 2292 includes a compliant interface, which may be made of a flexible, resilient material, such as, but not limited to, silicone or thermoplastic elastomers. The sealing cushion is configured to form a substantially airtight breathing channel for sealing around the user's nose. The connector portion 2294 is made of a substantially rigid material, such as, but not limited to, polycarbonate, and includes a circular opening 2296 opposite to the sealing cushion 2292. The connector portion is configured to provide a reusable, removable connection between the cushioning module 2290 and the frame assembly 2280. The cushioning module 2290 and the frame assembly 2280 are joined together such that an air path is formed through the tube connector 2286 and the bend 2284 and into the cushioning module 2290, as... Figure 81 As shown.

[0751] Figure 82 and 83The method by which frame assembly 2280 is attached to housing 2240 of headgear system 2200 is illustrated. Bend 2284 and tube connector 2286 are configured to pass through the central opening of housing 2240 to attach frame 2282 to rear surface 2310 of housing 2240. A portion of frame 2282 extends through the central opening 2248 of housing 2240 and is substantially flush with front surface 2300 of housing 2240.

[0752] The rear surface 2320 of frame 2282 is in Figure 83 and 84 As shown in the diagram, the rear surface 2320 of frame 2282 includes several protrusions that form a circular inner sleeve 2420 around the periphery of the socket of the connector 2400 and socket 2410. The inner sleeve 2420 has multiple cutouts 2430 to provide flexibility. A recessed channel 2450 extends around the periphery of the inner sleeve 2420. The recessed channel 2450 retains the circular opening 2296 of the buffer module 2290 in a snap-fit ​​configuration. There are one or more (e.g., a pair) bonding features 2440 located on the lower periphery of the recessed channel 2450. The bonding features 2440 are configured to interact with corresponding features on the connector portion 2294 of the buffer module 2290, thereby preventing rotation of the buffer module 2290.

[0753] The advantage of the headgear adjustment system disclosed in the previously described embodiments is that it provides a silent adjustment mechanism. In the prior art, hook-and-loop fastening systems (such as Velcro) are often used to provide size adjustments to headgear systems used with breathing masks. When the tightness of the headgear system needs to be adjusted, the hook-and-loop fastener components must be disengaged from each other. Disengagement of the hook-and-loop fastener components typically produces a cracking sound, which can be annoying to the mask user and, in some cases, may wake the user's bed partner. The headgear system disclosed herein is unlikely to require manual adjustments by the user to achieve an improved size and fit, and any adjustments required will not generate noise, or at least not a significant level of noise, thereby improving ease of use and enhancing the comfort of the user and their bed partner.

[0754] Head and hat test:

[0755] Figure 85 A test apparatus is shown for verifying the function of a headgear device including at least one directional locking module 2510. Figure 85The hood device under test comprises a hood 2502 and a mask frame 2504 connected together by a pair of lateral directional locking modules 2510. The frame 2504 is configured to receive a nose pad seal. The ends of the directional locking modules 2510 attached to the hood are held within a test bench 2520, which secures the hood device to a movable crosshead 2530 of a universal testing machine. The mask frame 2504 is secured to a fixed crosshead 2540 of the universal testing machine. The universal testing machine can run tests simulating the donning and wearing of a mask in several phases. It should be understood that this testing apparatus can be modified to test hood devices configured for use with different mask types, such as full-face masks and nasal masks.

[0756] The first stage of the test simulated the donning of the mask and hood assembly. The moving crosshead was programmed to pull the hood away from the frame, causing the directional locking module to extend until the hood assembly approached its maximum circumference. The second stage of the test simulated the fit of the mask and hood assembly to the user's head. The universal testing machine was programmed to return the hood to the mask frame a certain distance, where the hood assembly's circumference was approximately midway between its maximum and minimum circumference. This simulated the point where the hood assembly's length matched the user's head circumference. The third stage of the test involved extending the hood assembly back to its maximum circumference, simulating the application of CPAP pressure and the use of the mask system. Force distribution was recorded throughout all three test stages.

[0757] During the first phase of testing, it is expected that the force-elongation plot should show the initial steep rise in force as the directional locking mechanism engages during the elongation of the cap assembly. If the plot does not show this, there may be some slack in the cap, and the test bench needs to be removed before the directional locking mechanism disengages. Following this steep rise in force, a transition point will be reached at or near a predetermined yield force. Once the yield force has been reached, the rate of force increase decreases and remains substantially constant until the maximum cap circumference is reached.

[0758] The second phase of the expected test is shown on a force-extension plot as the instantaneous release of the directional locking mechanism. The initial sharp drop in force indicates the instantaneous release of the retaining gasket (or other suitable locking mechanism) as the extension force is released from the headgear assembly. The return force is driven by the elastic component ...

Claims

1. A headgear assembly (1500) for supporting a breathing port (1520) on a user, comprising: The latter part is essentially inelastic (1530). The essentially inflexible front section (1540) is configured to connect to the breathing interface; The first elastic side portion (1550) on the first side of the headgear assembly. The second elastic side portion (1550) on the second side of the headgear assembly. At least one filament (1570) extends through at least one of the first elastic side portion and the second elastic side portion or extends along at least one of the first elastic side portion and the second elastic side portion, said at least one filament being connected to one of the non-elastic rear portion and the non-elastic front portion; At least one restraint device (1510); The at least one filament passes through the at least one restraining device, which is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one restraining device. Wherein, the at least one constraint device is configured to: (i) provide a first resistance to the movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from each other, and (ii) provide a second resistance to the movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move toward each other, the second resistance being less than the first resistance; The inelastic rear portion, the inelastic front portion, the first elastic side portion, and the second elastic side portion define the periphery of the closed loop.

2. The headgear assembly as claimed in claim 1, wherein, The inelastic front part is rigid.

3. The headgear assembly as claimed in claim 1 or 2, wherein, The non-elastic front portion is configured to be removably attached to the breathing interface.

4. The headgear assembly as described in any of the preceding claims, wherein, The inelastic front portion defines at least one collection channel (1542) to accommodate a portion of the at least one filament.

5. The headgear assembly as described in any of the preceding claims, wherein, The inelastic front section is curved, and the collection channel is curved along with the inelastic front section.

6. The headgear assembly as described in any of the preceding claims, wherein, Each of the first and second elastic side portions includes an end cap (1556) with an opening through which the at least one filament passes.

7. The headgear assembly as claimed in claim 6, wherein, The end cap is attached to the non-elastic front portion.

8. The headgear assembly as described in any of the preceding claims, wherein, The filaments define a hard stop at their maximum elongation to limit the elongation of the cap and to limit the maximum circumference of the cap.

9. The headgear assembly as described in any of the preceding claims, wherein, The at least one filament includes a first filament associated with a first elastic side portion and a second filament associated with a second elastic side portion.

10. The headgear assembly as claimed in claim 9, wherein, The at least one constraint device may include a first constraint device associated with a first elastic side portion and a second constraint device associated with a second elastic side portion.

11. The headgear assembly as claimed in claim 9 or 10, wherein, The at least one collection channel includes a first collection channel that accommodates a portion of a first filament and a second collection channel that accommodates a portion of a second filament.

12. The headgear assembly as claimed in any of the preceding claims, wherein, The restraint device includes a directional lock comprising a housing (1810) defining an internal space (1840, 1842), a first opening (1860), and a second opening (1860), each of the first and second openings communicating with the internal space; the directional lock includes at least one locking element (1820, 1822) pivotally coupled to the housing for rotation about a fixed pivot axis, said at least one locking element including an aperture (1876) configured for receiving a filament. The at least one locking element is movable between a first position and a second position, in which the orifice is aligned with a first opening and a second opening, and in the second position, the orifice is not aligned with the first opening and the second opening.

13. The headgear assembly as claimed in claim 12, wherein, The at least one locking element includes a first locking element and a second locking element.

14. The headgear assembly as claimed in claim 13, wherein, The housing includes an inner wall (1812) positioned between the first locking element and the second locking element.

15. The headgear assembly as claimed in claim 14, wherein, The inner wall includes an opening (1860) through which the filament passes; when the locking element is in the first position, the opening and the orifice are aligned in a substantially straight line, and when the locking element is in the second position, the path of the filament through the directional lock is non-linear or tortuous and the movement of the filament is restricted.

16. The headgear assembly as claimed in any one of claims 13-16, wherein, The first and second locking elements include a shaft (1824) and an arm (1826) extending from the shaft, each arm including an aperture for a filament to pass through.

17. The headgear assembly of claim 16, wherein, The arm comprises a first section (1872) and a second section (1874), the first section extending radially or vertically from the axis, and the second section extending at an obtuse angle from the end of the first section.

18. The headgear assembly as claimed in any of the preceding claims, wherein, The first elastic side portion and / or the second elastic side portion include woven, knitted, or machine-woven elements.

19. The headgear assembly as claimed in any of the preceding claims, wherein, The first elastic side portion and the second elastic side portion are tubular and hollow in cross-section, and filaments extend through at least one of the first elastic side portion and the second elastic side portion.

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